http://www.arcs.com.au/ en-au http://www.arcs.com.au/NewsDetails.aspx?NewsID=870 Press Release: Evado, a clinical software provider, today announced the opening of a new office in San Francisco, California, USA. The newly appointed Director of Business Development, Ms Maria Chiam will operate from Evados US office Wed, 25 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=869 nbsp; Trials, 16Jan12: Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial Nature Biotechnology, 9Jan12: Reinventing Clinical Trials. Get ready for electronic data capture, precompetitive data sharing, virtual trials and a variety of bold new paradigms. PLOS One, 9 Jan12: Comparative Effectiveness Research: An Empirical Study of Trials Registered in ClinicalTrials.gov Applied Clinical Trials, 1Jan12: Limited Resource Trials - Examining the challenges and solutions to the implementation of trials in resource-limited settings. Applied Clinical Trials, 1Jan12: Imperatives to Share Trial Results with Volunteers Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=868 BioSpectrum Asia: In the last few months, Taiwan has taken some strategic steps that have the potential to position it among the lucrative markets of Asia, therefore drawing Asian and global attention for investments, clinical trials and joint research projects Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=867 ChinaBio Today: The annual J.P. Morgan Healthcare extravaganza, held in San Francisco, was buzzing with excitement about China. A total of 15 companies, ranging from highly innovative to branded generics drug companies, as well as CROs and distributors, presented their plans for continued growth in China’s expanding market. Each one was strongly positive about their prospects in China as well as the market overall Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=866 Mass Device: Biotronik, the Berlin-based remote monitoring technology maker, plans to open an Asian headquarters in Singapore as part of a larger commitment to strengthening its presence in the Asia Pacific region, the company announced Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=865 Fierce Biotech:Quintiles has mapped out plans to open its fourth hub in China with plans to hire 500 workers for a new business process outsourcing operation that will cater to a broad range of biopharma clients with a multilingual staff based in Dalian. The move comes just weeks after Quintiles announced plans to set up a new CRO based in Beijing Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=864 The Sunday Leader:In a strange twist of events, the proposed Clinical Drug Act will not be supervised by the Ministry of Health, but instead by the Ministry of Finance, professionals in the health sector claim. The Act, still in draft form, will provide guidelines to allow for drugs to be tested on humans Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=863 BioSpectrum Asia: An Accenture survey of more than 3,700 doctors across eight countries reveals that Singapore physicians agree strongly with the benefits of healthcare IT and a majority of them (69.1 percent) believe its most important contribution is better access to quality data for clinical research Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=862 nbsp; 17Jan12 - Japan - The Basic Concept on Regulatory Science at PMDA – This document explains the regulatory science policy at Japan’s PMDA Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=861 PharmaTimes: The smartphone application market for mobile healthcare increased seven-fold to reach $718 million in 2011, but is set to rise much more. That is one of the key findings of a report from research2guidance, mobile market research specialists Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=860 PharmTech Blog: A new journal website offers the industry opportunities to see through video how other scientists carry out particular experiments and processes Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=859 Genetic Engineering News: Intent on shepherding more biopharma companies to market and keeping them growing, Prime Minister David Cameron recently unveiled a “Strategy for U.K. Life Sciences”. Part of the strategy includes plans to launch a new app and an improved U.K. Clinical Trials Gateway web portal in March Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=858 e-Patients.net: Thoughts from MIT Media Lab’s third annual Health & Wellness Innovation event - a two week competition where six teams pursue some terrific ideas for the most patient-friendly health innovations Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=857 MarketWatch: The Tufts Center for the Study of Drug Development today announced that it has established the first global benchmark for clinical research associate (CRA) workload and utilization, giving managers’ insights into improving CRA effectiveness and efficiency Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=856 PharmaTimes: Novartis has the best corporate reputation out of 30 companies within the pharmaceutical industry, according to a survey of 500 large and influential patient groups worldwide Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=855 PharmaTimes: There is a “striking perception gap” between CROs and their clients over the direction this relationship is taking. A new report from the Economist Intelligence Unit (EIU) found CRO’s intend to start or expand assay-development services and screening services while potential clients “expect to increase their use of CROs largely in fields in which they are already most frequently used, such as drug trials” Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=854 Harvard Business Review: In our survey of 30 successful global leaders, it seems lead their companies differently than their peers. Most strikingly, they pioneer a leadership style which engages people in very different settings Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=853 OutsourcingPharma: The EMA has warned sponsors must take “great care” when outsourcing to niche subcontractors to avoid violating GCP Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=852 nbsp;MarketWatch: Three IT trends will shape the life sciences in 2012, according to an analysis by SAFE-BioPharma Association. They are the expanded use of standards-based interoperable digital identities, cloud computing in clinical trials, and the use of electronic trial master files for clinical trial management Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=851 CentreWatch: The FDA completed its recommendations Jan. 17 for three user fee programs to help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=850 Mass Device: The FDA missed its 2nd deadline for submitting a proposal to Congress for the Medical Device User Fee & Modernization Act, which is set to be renewed this year, as negotiations with the medical device industry drag on Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=849 CentreWatch: Driven by rapid innovation made possible in large part by the mapping of the human genome, genetic and genomic clinical laboratory testing generates 116,000 U.S. jobs and contributes $16.5 billion annually to the U.S. economy Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=848 nbsp; 20Jan12: FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri 18Jan12: “Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage” - provides sponsors of an IDE or an IND recommendations about certain information that should be included in a submission describing a product intended to repair or replace knee cartilage Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=847 nbsp; 20Jan12: The European Medicines Agency has recommended the suspension of all marketing authorisations for meprobamate-containing medicines for oral use in the European Union, because their risks outweigh the benefits. 20Jan12: The European Medicines Agency has released a guideline on how pharmaceutical companies should test biosimilar medicines containing interferon beta for public consultation. Consultation closes at the end of May Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=846 The Office of the National Health and Medical Research Council has developed the Research Governance Handbook: Guidance for the National Approach to Single Ethical Review in consultation with stakeholders to provide guidance on Research Governance requirements for Multi-Centre Research. The Handbook is available on the Human Research Ethics Portal at http://hrep.nhmrc.gov.au/toolbox/guidance-multi-centre-research Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=845 Australian Life Scientist: Deal with US pharmaceutical company Ironwood to develop anti-anxiety compound BNC210 could be worth up to US$345 million for the Adelaide-based biotech Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=844 AMA: The AMA welcomes the decision by the Privacy Commissioner to issue a fresh public interest determination covering the collection of family and social medical histories by medical practitioners and other health service providers. This determination ensures that doctors can continue to collect third party health information that is relevant to a patients family or social history without the family member having to give their consent Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=843 NSW Govt: Almost $7 million has been granted to two eminent research groups, in the latest injection from the NSW Government’s translational cancer research program. The funding is in addition to the $30 million over 5 years already provided by the NSW Government for this hugely beneficial program Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=842 GMIA: A new Government-funded survey into the increased use of medicines by an ageing population underscores the need for policies that encourage the uptake of high quality generic medicines, says the peak body for the generic medicines sector in Australia Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=841 AHHA: A study by NPS in collaboration with the University of Melbourne —published today in the Medical Journal of Australia — has provided new insights into how people use medicines on a daily basis and highlights that the use of multiple medicines in older Australians is common and more complex than previously thought Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=840 Ministerial Media Release: The Minister for Mental Health and Ageing, Mark Butler, and the Minister for Families, Community Services and Indigenous Affairs and Minister for Disability Reform, Jenny Macklin, invited Australians to help carve out the future of our mental health system with the release of the draft Ten-Year Roadmap for National Mental Health Reform for public consultation Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=839 Australian Life Scientist: UniQuest spinoff and pharmaceutical R&D company Janssen-Cilag will combine resources to support the development of a rheumatoid arthritis treatment Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=838 Monash Uni: The first Australian patient with leukaemia has been treated with a new investigational anti-cancer drug in a phase 1 trial sponsored by the US Company, KaloBios Pharmaceuticals. The drug, KB004, a therapeutic antibody designed to target and destroy cancer cells in blood cancers and solid tumors Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=837 The Australian, via Aus Health IT Blog: The Gillard government has abandoned any intention of creating an independent oversight body for the future operation of its controversial personally controlled e-health record system, due to launch on July Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=836 nbsp; 20Jan12: Poly Implant Prothese (PIP) breast implants - the Australian perspective Tue, 24 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=835 Fox News Chemotherapy drugs, the first line of defense for a common form of adult leukemia, could actually be contributing to the disease’s rate of relapse in patients Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=834 MassDevice: Biomedical CEOs in California continue to see a burdensome FDA regulatory environment as a major hinderance to the industries growth, according to preliminary results of a CEO survey conducted by the California Healthcare Institute, BayBio and PwC Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=833 CentreWatch: Today, 282 medicines to treat children and adolescents are in clinical trials or under review by the FDA, according to a report by Pharmaceutical Research and Manufacturers of America (PhRMA Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=832 Reuters: Burned by disappointing early sales for new, high-profile biotech medicines in 2011, healthcare investors are cautious ahead of this years expected crop of drug launches Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=831 BMJ: At least four members of a key committee advising the US Food and Drug Administration on the safety of a top selling drug have had financial ties to its manufacturers, raising questions about the rigor with which the agency minimises potential conflicts of interest Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=830 OutSourcing-Pharma: Major CRO consolidation will slow down in 2012 after the big wave of deals last year, the CEO of Icon said Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=829 PharmTech Blog: GlaxoSmithKline has faced intense media scrutiny this week after being fined approximately 72 650 Euros by a court in Argentina for allegedly conducting unethical clinical trials on children for the company’s pneumococcal vaccine, Synflorix Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=828 InPharm A new survey shows pharma is not prepared to deal with the tough year ahead as many blockbuster drugs begin to go off patent Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=827 CenterWatch The FDA has trained a watchful eye on Johnson & Johnson as delayed reports, recalls and court trials pile up Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=826 NYTimes: The nicotine gum and patches that millions of smokers use to help kick their habit have no lasting benefit and may backfire in some cases, according to the most rigorous long-term study to date of so-called nicotine replacement therapy Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=825 nbsp; MHRA:UK Pharmacovigilance consultation: The MHRA have launched a public consultation to seek views on the transposition into UK law of the EU Directive on pharmacovigilance, which comes in to effect in July 2012. Comments are invited by Feb 28, 2012. Health Canada, 9Jan12: Release of revised guidance document for consultation: considerations for inclusion of women in clinical trials and analysis of data by sex. This consultation is open for comment until March 9, 2012 SFDA, 12Jan12: SFDA further standardizes the registration of drug substances mixed powder. The SFDA recently issued a notice to clarify the relevant requirements on the registration of drug substances mixed powder used for the pharmaceutical preparations Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=824 Jan12: FDA completes work on three drug user fee programs. The FDA has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=823 Jan12: Public consultation opens on the revised guideline on the evaluation of human anticancer medicines. The EMA has launched a public consultation on the revised guideline on the evaluation of human anticancer medicines. The purpose of the guideline is to provide guidance on all stages of clinical drug development for the treatment of malignancies, including drug resistance modifiers or normal tissue protective compounds Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=822 nbsp; Trials Journal, 13Jan12: Involvement of consumers in studies run by the Medical Research Council (MRC) Clinical Trials Unit: Results of a survey Applied Clinical Trials, 10Jan12: The Pharmaceutical Safety Data Problem Trials Journal, 8Jan12: Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience Harvard Business Review: Make Your Cubicle a Better Place to Work Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=821 PharmaBiz: India is fast emerging as a hub for paediatric oncology drug trials. Currently, major hospitals are carrying out studies on paediatric cancer cases Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=820 Pharmalot: The Indian health ministry 2 months ago issued new rules that give Ethics Committees the latitude to review any injuries or deaths that occur during clinical trials and also establish compensation (read the rules here). The proposal, however, has drawn the ire of the Association of Clinical Research Organizations, the trade group, which recently wrote a scathing letter to Indian officials in which they blast Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=819 MassDevice: Chinas medical device market is set to grow 17% in 2012, according to a Citigroup hospital survey. GE Healthcare leads the Chinese medical equipment market, but in orthopedics and drug-eluting stents, Medtronic, Johnson & Johnson and Stryker take the lead, according to the report Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=818 PharmaTimes: ShangPharma, the contract research organisation that last October nearly tripled its research-model capacity by acquiring the assets of Charles River Laboratories’ in vivo pharmacology facility in Shanghai, has further expanded its laboratory and office space to service the growing needs of one of its largest clients, Eli Lilly Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=817 The Hindu: Public health activists and womens rights groups have raised concerns over compensation-related amendments to the Drugs and Cosmetic Rules 2011 proposed by the Union Health Ministry for subjects of clinical trials. They have suggested wider consultations before the amendments are notified Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=816 ABC Hospitals are running short of an important drug used to treat several forms of cancer after its American manufacturer decided to temporarily halt production Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=815 HealthReporter: Countries that advise women to remove their PIP breast implants following international concern about the implant quality are not acting on any rational scientific data according to a leading breast implant surgeon. Related: TGA 12-Jan-2012 Information regarding tests that have been conducted on silicone gel filled breast implants manufactured by Poly-Implant Prothese (PIP) TGA 12-Jan-2012 Questions and answers for consumers about breast implants Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=814 SMH The Therapeutic Goods Administration has let Australians down … again Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=813 CIO: NeHTA will maintain its current design for personal e-health records despite acknowledging concerns that increased consumer control over health information could potentially result in poorer health outcomes for patients Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=812 Aus Med Industry Blog:The Australian Medicines Industry made available no fewer than 21 brand new medicines to Australian patients through the Pharmaceutical Benefits Scheme. These include four new medicines to treat Type 2 diabetes, four for hypertension, three for rheumatoid arthritis and other treatments for prostate cancer, osteoporosis, migraines and infertility Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=811 NHMRC Ethics Committee Portal The NHMRC has released the following two documents/tools in support of multi-central ethical review. 1. National, State & Territory Legislative Framework 2. Framework for Monitoring: Guidance for the national approach to singe ethical review of multi-centre Research Both documents can be found on the Human Research Ethics Portal Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=810 QLD Health RegU: Mutual Acceptance has progressed with commencement of single ethics review of multi-centre clinical trials between Queensland and Victoria on 24 October 2011. There has been good uptake and interest from researchers and sponsors/CROs. A total of 12 applications have been booked through the central allocation and coordinating services to date Mon, 16 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=809 ClinicalLeader: China has a relatively short history of drug safety surveillance — compared with the United States, many European countries, and Japan — but, just as its economy is growing at a rapid clip, so, too, is its system for watching over drug safety. With nearly 1/5 of the worlds population, Chinas potential contribution to global medical safety is gigantic Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=808 LiveMint: Global drug makers may have turned risk-averse towards buying or forming partnerships with Indian makers of generic medicines after being hit by revenue losses stemming from quality and compliance issues over previous acquisitions and tie-ups, deal makers say Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=807 Business Standard: The central government’s plans to introduce a new rule under the existing Drugs and Cosmetics Act to compensate clinical trial victims has been challenged before the Lucknow bench of the Allahabad High Court Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=806 Himalayan Times: Nepali pharmaceutical companies have only around three months left to register and maintain standards abiding by Good Manufacturing Practice (GMP) recommended by World Health Organisation (WHO) guideline. The deadline for meeting GMP is mid-April Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=805 In-Pharma Technologist:India has released draft guidance on stability data needed to support approval of Phase I to III clinical trials Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=804 LiveMint: dia is seeing a decline in the number of human clinical trials because of time-consuming government approvals and rising allegations of unethical tests further hindering possibilities of gathering a large sample size of people Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=803 nbsp; Psychology Today, 4Jan11: Clinical Trials and Drug Approval: Why Placebos are Essential BMJ, 3Jan12: Missing clinical trial data (Editorial with links to the 6 BMJ articles referenced by Reuters 4Jan11 article) JCRBP, 2Jan11: The 3 page informed consent form JCRBP, 2Jan11: Fixing the protocol feasibility process PLOS Medicine, 27Dec11: Disclosure of Investigators Recruitment Performance in Multicenter Clinical Trials: A Further Step for Research Transparency (Argues that recruitment performance (target + actual recruitment) should be disclosed on clinicaltrials.gov.) Nature, 22Dec11: Perspective: The clinical trial barriers (A need to re-think the way traditional Asian medicines are tested). PLOS One, 9Dec11: Cochrane Systematic Reviews of Chinese Herbal Medicines: An Overview Brit J Diabetes Cardiovascular Disease, Dec 11:The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance: application to diabetes and vascular disease Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=802 Clinical Leader: Businesses with preferred provider lists should have an internal system to gather feedback throughout the course of the project and after its completion, as well as a way of evaluating the outside factors that can influence performance, such as staff changes or impacts to operations or personnel caused by a merger or acquisition Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=800 PharmaTimes: The Innovative Medicines Initiative (IMI) has announced an agreement with the US-based Clinical Data Interchange Standards Consortium (CDISC) that will see IMI project teams adopt CDISC formats and standards to harmonise data management across the two organisations Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=801 Manufacturing Chemist: The European Commission says an EU-funded €1.3m research project aimed at improving pharmacovigilance in Mediterranean countries has been successful Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=799 PR NewsWire: Responding to a need for better post-market surveillance of orthopedic devices, the US FDA established the International Consortium of Orthopaedic Registries in October 2010. As outlined in a Dec. 21 special online supplement in the Journal of Bone and Joint Surgery, ICOR is in the process of developing a collaborative process for improving the safety of orthopedic devices using outcomes registries from the U.S. and other countries Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=798 MarketWatch: In a move aimed at bolstering current systems for assessing and monitoring drug safety, researchers at Childrens Hospital Boston have created a new mathematical method that combines multiple forms of widely available data to predict adverse drug reactions Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=797 Malaria Matters: Monitoring the safety of antimalarial drugs at the community level possess a challenge to effective pharmacovigillance. Though, spontaneous reporting of events has been the easiest way of monitoring drug safety, these reports are not as expected. This paper investigates how mobile phone calls can be used to monitor antimalarial safety in rural Dangme West District Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=796 CentreWatch: Pharmaceutical companies are outsourcing drug research more frequently, and when they do they are handing off larger portions of the operation than ever before, reports Kalorama Information Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=795 Hindu Business Line: The Association of Contract Research Organisations is planning to release a code of conduct for clinical research/trials soon, according to its Chairman Mr Apurva Shah Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=794 Medical Xpress: In a commentary published in the November issue of Academic Medicine, top recruitment experts at UCSF urge academic medical researchers to embrace new methods for recruiting participants into clinical trials Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=793 NY Times: These days, it is often not enough for pharmaceutical companies simply to bring a drug to market. Regulators and insurers are also prodding the companies to develop tests to pinpoint which patients are most likely to benefit from a drug, thereby sparing other patients from needless side effects and expense. Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=792 MHRA: In May 2011 40 questionnaires were sent out to organisations that had undergone a GCP inspection between July 2010 and December 2010. In general the 19 organisations that responded to the GCP questionnaire reported a high level of satisfaction with the inspection process and the conduct of the inspectors themselves Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=791 Quintiles: Quintiles have announced the formation of its new Digital Patient unit. The goal of the new Unit is to provide patients with information to better manage their personal health and to provide them with opportunities to participate in clinical research, observational studies and programs to better manage their conditions Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=790 MarketWatch: A group of thought leaders in Alzheimers disease says the science is solid and the time has come for more widespread use of biomarkers in Alzheimer disease (AD) clinical trials, to speed the identification of effective disease-modifying treatments for this incurable disorder Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=789 Reuters: In a series of studies for the BMJ on the extent to which clinical trial data are made public, researchers found a large proportion of evidence was unreported and much of what was reported by pharmaceutical firms was inadequate. Related: iHealthBeat: Researchers Fail To Report Clinical Trial Data to clinicaltrials.gov Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=788 Forbes: Two Danish diabetes researchers claim that the pharmaceutical industry may be manipulating independent clinical research by controlling access to placebo drugs or devices Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=787 The Scientist:Data from early stage clinical trials are not being widely reported, thus putting patients at risk, according to a handful of new studies in the British Medical Journal. The missing data includes both safety and efficacy findings that go unreported or are published in obscure places Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=786 CentreWatch: A new CentreWatch analysis reveals that the global landscape of investigator sites has continued to shrink and has become more unstable over the past five years. The most active and experienced investigative sites have seen the sharpest decline Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=785 Mass Device: About 460 companies were bought for $46.4 billion last year, down 13% from 2010, but the deals were valued 30% higher, compared with the $35.6 billion spent in 2010, according to a Dow Jones VentureSource report Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=784 Nanotechnology Now: Concerned by the growing body of scientific reports cautioning against the unregulated use of nanotechnology in consumer products, a coalition of nonprofit consumer safety and environmental groups sued the FDA today, demanding a response to the petition they filed nearly 6 years ago. The case is the first lawsuit over the health and environmental risks of nanotechnology and nanomaterials Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=783 FierceBiotech: PPS Clinical Research reportedly paid a $68,000 fine and pled guilty to a federal obstruction charge after acknowledging an employee at the CRO had doctored patient records for clinical trial work on Boehringer Ingelheims Flibanserin. $206,000 was also paid to settle a civil case Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=782 Bloomberg: U.S. approvals of new drugs hit a seven-year high last year as pharmaceutical companies responded to regulators’ demands for better safety data and avoided last- minute requests for more information. The FDA cleared 30 new treatments in 2011 compared with 21 the year before Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=781 nbsp; 29Dec11: Draft Guidance for Industry: Use of Histology in Biomarker Qualification Studies 27Dec11: Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=780 nbsp; 22Dec11: Guideline on the evaluation of anticancer medicinal products in man 22Dec11: Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man 20Dec11: Draft VICH GL34: Biologicals: testing for the detection of mycoplasma contamination. Consultation open until 12Mar12. 20Dec11: Draft VICH GL51: Quality: statistical evaluation of stability data. Consultation open until 12Jun12. 19Dec11: European Medicines Agency issues revised guidance on genotoxicity testing of medicines. The revised guideline comes into effect in June Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=779 Medicines Australia: Medicines Australia chairman Will Delaat announced today that he will retire from the position in February Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=778 Aus Medicine Industry Blog: These two individuals have led changes in IT that have transformed the world, improved peoples’ access to information and thereby helped drive the connectedness of humanity. So how do their thoughts on innovation stack up with what is happening in the medicines industry? Their perspectives on innovation in the medicines industry have been captured in a couple of recent articles in Forbes business magazine Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=777 SMH: Mixing and measuring medicine is making a comeback as pharmacies try to differentiate themselves from discount and warehouse chemists. This is being driven by competition, increased consumer awareness of doses not available in Australia, increased allergies, lack of availability of medicines in children’s doses, etc. The growing industry faces several challenges Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=776 Medicines Australia: The Australian medicines industry’s contribution to the economy grew by an estimated $1 billion year-on-year, and its turnover rose by almost $400 million according to a new industry “Facts Book” published today Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=775 The Warrnambool Standard: Warrnambool has consolidated its position as a regional player in vaccine research, with patients previously having to travel to Melbourne to participate in clinical studies Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=774 nbsp; 23Dec11: Resignation of Dr Rohan Hammett. 19Dec11: Presentations about manufacturing therapeutic goods - Added National Validation Forum presentation Open consultations: o Proposed revisions to the Australian regulatory guidelines for over-the-counter medicines (ARGOM). Closing date: 11 February 2012 o Notice inviting public submissions under Regulation 42ZCZK of the Therapeutic Goods Regulations 1990. Closing date: 19 January 2012 o Interim decisions & reasons for scheduling decisions and invitation for further submissions. Closing date: 13 January Tue, 10 Jan 2012 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=773 China Daily: China will strengthen the regulation of traditional Chinese medicine (TCM) to ensure its quality and to assist the countrys plans to provide universal healthcare Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=772 PharmaBiz: The Central Drugs Standard Control Organisation (CDSCO) will soon amend the Drugs and Cosmetics Act (D&C Act) to make compensation mandatory in case of injury or death during clinical trial Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=771 PharmaTimes: Semler Research Center (SRC), a privately owned pharmaceutical services company with offices in Los Angeles, US and Bangalore, India, has launched an Asia CRO Alliance (ACA) with a physical presence in six countries and capability to deliver contract research services in a total of 14 countries across Asia Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=770 HBR Blog: Geopolitical uncertainty remains an issue; infrastructure and cultural barriers might constrain growth. But the overarching trend is a shift in the worlds innovation energy. If you are a Western executive making New Years resolutions, consider adding a visit to Mumbai, Manila, Bangkok, Singapore, Hong Kong, Shanghai, Seoul, or Jakarta to your list. This post discusses the three biggest trends I see affecting innovation in the region Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=769 Asian Correspondent: China promised Saturday to impose harsh new penalties on makers of contaminated drugs, the latest in a series of recent high-profile government efforts to improve drug safety Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=768 National Law Review: The Chinese government has begun to respond to concern over the efficiency and integrity of the clinical trial process in China and of complaints that the clinical trial stage of biomedical innovation has become a bottleneck for the licensing of new drugs and devices in China with new guidelines and draft legislation Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=767 PharmaTimes: US-based biopharmaceutical services company Quintiles has intensified a 14-year commitment to the Chinese market by launching a local contract research organisation, Kun Tuo Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=766 Indian Express: During Prime Minister Manmohan Singh’s three-day Russia visit, drug controllers of the two nations will sign a memorandum of understanding under which they will share information about drug adverse effects and regulation frameworks. The partnership could go on to recognise each other’s drug approval processes Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=765 nbsp; 13Dec11, Trials: A statistical framework for quantifying clinical equipoise for individual cases during randomized controlled surgical trials 13Dec11, PLOS Medicine: The Role of Group Dynamics in Scientific Inconsistencies: A Case Study of a Research Consortium 7Dec11, PLOS Clinical Trials: Two-Way Minimization: A Novel Treatment Allocation Method for Small Trials 5Dec11, Pharm Stats: Why a Bayesian approach to safety analysis in pharmacovigilance is important. 12Dec11 Knowledge at ASB: Employee Safety: New Rules on the Risks of Working from Home Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=764 Eye on FDA Blog: Social media has changed the landscape of communications – pervasively. And yet recruitment for clinical trials – and support of patients in them – for the most part occurs the way it did fifteen years ago. Why Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=763 Harvard Business Review: What can we expect in 2012 in a world that seems to grow ever connected by the hour? Here are six predictions to ponder Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=762 PharmaTimes: While some National Health Service Trusts in England are engaging forcefully with the clinical research agenda promoted by government, the NHS and organisations such as the National Institute for Health Research (NIHR), there remain broad disparities across the region in terms of study participation and the number of patients recruited, NIHR data show Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=761 NCI: The NCIs Board of Scientific Advisors has approved a proposal to fund a new integrated NCI Clinical Trials Network (NCTN). Under the proposal, NCI would fund no more than five clinical trials groups (up to four adult groups and one pediatric group), as well as centers to provide support for core services, such as imaging and radiation therapy. Per patient reimbursement will increase for high-performing centres Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=760 MassDevice: Former Synthes VP Richard Bohner gets 8 months in prison for his role in illegal bone cement trials conducted by subsidiary Norian that left three dead Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=759 Reuters: Big drugmakers, under pressure to streamline operations in the face of rising costs and slowing sales, are looking to the automotive industry for tips on tuning up their profit engines Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=758 Bio-IT World: The Multiple Myeloma Research Consortium (MMRC) has been able to accelerate the clinical trials process by making improvements to trial start-up and enrollment as well as patient accrual for oncology clinical trials run through the Consortium Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=757 La Jolla Light: UCSD clinical professor Georgia Robins Sadler discussed the many roadblocks in the recruitment of subjects for clinical trials with an audience at the Reuben H. Fleet Science Center in a talk entitled “What the public needs to know about clinical trials” Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=756 PharmaTimes: Ratings agency Fitch has issued a report saying the pharmaceutical sector will "continue to experience significant operating challenges" in 2012 but while issuing a negative outlook, it will still be one of the highest-rated industries. Challenges will include "an unprecedented period of patent expiration", plus increasing government cost-containment and demand pressures, "stemming from relatively high unemployment and low consumer confidence Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=755 PRWeb via SFGate: The Innovative Medicines Initiative Joint Undertaking (IMI - joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA)) and the Clinical Data Interchange Standards Consortium (CDISC) have signed an agreement and initiated activities to enhance the use of information gathered for the purpose of developing safer, more effective innovative medicines for patients Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=754 MobiHealthNews: Healthline, a consumer health search engine, published a list of 2011’s most-searched health and medical terms via both desktop computers or laptops (web searches) and via mobile devices (mobile search). The published data reveals significant differences in what consumers search for from the privacy of their mobile devices vs. from PCs Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=753 MassDevice: Basic differences such as genetics, hormones, body size, diet and socio-cultural issues may play a role in the efficacy of medical devices in patients, the FDA said. The FDA have issued a draft guidance today designed to increase the number of female subjects enrolled in med-tech clinical trials Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=752 BioEdge: Current rules and regulations provide adequate safeguards to mitigate risk in clinical trials, says the Presidential Commission for the Study of Bioethical Issues. The report, Moral Science: Protecting Participants in Human Subjects Research, recommends 14 changes to current practices to better protect research subjects, and calls for better tracking of government funded research programs, but basically gave US research a clean bill of health Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=751 nbsp; 13Dec11, InPharm Technologist: Joint FDA-EMA inspection programme to launch in January 2012 - The FDA and the EMA will begin sharing facility inspection data in their respective territories from January. The TGA, who was involved in the pilot scheme, won’t be involved Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=750 nbsp; 16Dec11: FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies 15Dec11: Draft Guidance - Humanitarian Use Device (HUD) Designations. This is intended to assist applicants in the preparation and submission of HUD designation requests to the FDA Office of Orphan Products Development (OOPD), and to assist FDA reviewers in their evaluation and analysis of those requests Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=749 nbsp; 16Dec11: The European Medicines Agency’s Management Board, at its meeting on 15 December 2011, adopted the Agency’s work programme and budget for 2012 which are driven by the implementation of the pharmacovigilance legislation. 15Dec11: The European Medicines Agencys pilot of involving patient representatives in scientific advisory group (SAG) meetings has been successful, according to the outcome report published today. Following the success of the pilot, the Agency intends to continue to invite 1 or 2 patient representatives to SAG meetings where their input is likely to be suitable and beneficial. 15Dec11: European Medicines Agency confirms positive benefit-risk balance of somatropin-containing medicines Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=748 PharmaTimes: Australias government has rejected official recommendations that drugmakers should be required to comply with an industry code of conduct before their products can be listed on the Australian Register of Therapeutic Goods (ARTG). The decision - which has been condemned by industry and consumer groups - forms part of the Gillard governments response to seven separate reviews of the TGA over the past 18 months Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=747 Medicines Australia: Medicines Australia congratulates outgoing Minister for Health and Ageing Nicola Roxon and outgoing Innovation and Industry Minister Senator Kim Carr on their contributions to their respective portfolios over the past four years, and welcomed the appointments of Tanya Plibersek as Minister for Health and Greg Combet as Minister for Industry and Innovation Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=746 Australian Life Scientist: Prime Minister Julia Gillard says her new ministerial line-up will give Labor new energy and fire power heading into Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=745 GMiA: Ensuring the Pharmaceutical Benefits Scheme (PBS) is sustainable and medicines remain affordable and accessible to all Australians regardless of where they live or what their socio economic background is must be a priority for the new Minister for Health Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=744 WA Health: WA Health clinicians who want to undertake health and medical research can now apply for a new Clinician Research Fellowship, Health Director General Kim Snowball said today. Mr Snowball said the fellowships would help backfill the clinical duties of WA Health staff who undertook research that was of direct relevance to improved healthcare. Applications for the fellowship grants close on Wednesday, 29 February Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=743 NHMRC: Minister for Health Tanya Plibersek has announced a further $114.2 million investment in health and medical research for 159 grants across 3 NHMRC funding schemes - Program Grants, Development Grants and Postgraduate Scholarships Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=742 DoHA: The Australian Government is investing $644,950 in nine new postgraduate scholarships to help outstanding young health and medical researchers work towards improving the health and wellbeing for young Indigenous Australians Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=741 BiteTheDust via Croakey: Drug companies continually breach their code of conduct, pay a fine which their industry body collects and then “donates” making the industry appear wonderful. As Jarrad Hall commented on Twitter: I wonder if we little people can do that. I feel like donating to charity, I might go speeding later. Related: 12Dec11, Medicines Australia: Medicines Australia funds mobile dialysis truck Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=740 NSW Health: NSW Chief Health Officer, Dr Kerry Chant, today launched a new interactive web-based application that puts health data at your fingertips. Dr Chant said Health Statistics NSW allows users to access data and tailor reports about the health of the New South Wales population for their own use Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=739 GMiA: This is the largest single price cut in PBS history. The impact of this reform will be extensive and will deliver substantial savings to government Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=738 nbsp; 14Dec11: Invitation for public comment - ACMS and ACCS meetings, February 2012. Closing Date 19Jan Wed, 21 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=737 nbsp; 8Dec11, NEJM: Learning about the Safety of Drugs — A Half-Century of Evolution 6Dec11, PLOS Medicine: The Primacy of Public Health Considerations in Defining Poor Quality Medicines 6Dec11, PLOS Medicine: Measuring the Population Burden of Injuries—Implications for Global and National Estimates: A Multi-centre Prospective UK Longitudinal Study 5Dec11, Trials: Reporting of participant flow diagrams in published reports of randomized trials. 23Nov11, BMJ; Random sampling versus random allocation Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=736 LifeScience Leader: China has a relatively short history of drug safety surveillance — compared with the United States, many European countries, and Japan — but, just as its economy is growing at a rapid clip, so, too, is its system for watching over drug safety Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=735 Theday.com: Chinas vaccine makers are gearing up over the next few years to push exports in a move that should lower costs of lifesaving immunizations for the worlds poor and provide major new competition for the big Western pharmaceutical companies Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=734 The Times of India: The Indian Council of Medical Research (ICMR) has sought proposals from doctors and health activists to advise on the new draft guidelines for compensation to people undertaking drug trails. The subjects will be compensated if they are injured during the trails. Proposals will be invited till December Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=733 SFDA: To enhance the management of laboratories for drug clinical trial biological sample analysis, and improve the quality and management of analytical data of biological samples, the SFDA recently formulated and issued the Guidance on Management of Laboratory for Drug Clinical Trial Biological Sample Analysis (interim Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=732 SFDA: To enhance the management of the Phase I clinical trial of drugs, effectively safeguard the rights, benefits and safety of trial subjects, and improve the research quality and management of the Phase I clinical trial of drugs, the SFDA organized the drafting and recently issued the Guideline on Management of Phase I Clinical Trial of Drugs (interim Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=731 PharmaTimes: AstraZeneca says it will reduce its US sales force by 1,150 managers and reps as part of its strategy to operate more efficiently in the country. Meantime, AstraZeneca has entered into an agreement to acquire Guangdong BeiKang Pharmaceutical Co, a privately-owned generics company. The proposed acquisition comes on the heels of their $200 million investment in a new manufacturing facility located in China Medical City, Taizhou Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=730 PharmaTimes: US giant Merck & Co is establishing an Asian R&D headquarters in Beijing, as part of a $1.5 billion investment into research in China over the next five years Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=729 ChinaDaily: The State Council approved a blueprint on Wednesday to establish a credit rating system and intensify monitoring of pharmaceutical groups to boost the countrys drug safety over the next five years Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=728 nbsp; 9Dec11: European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections. 7Dec11: Experts and regulators discuss role of modelling and simulation in medicine development and regulatory assessment Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=727 CentreWatch: America’s biopharmaceutical research companies are testing 88 medicines and vaccines to treat or prevent HIV/AIDS and related conditions, according to a report by the Pharmaceutical Research and Manufacturers of America (PhRMA Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=726 Amednews: Caregivers want technology that can help facilitate the care of loved ones. Not only can physicians provide those tools, they also can benefit from them Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=725 PharmaTimes: AstraZeneca (AZ) has added its weight to the open-innovation agenda as an antidote to R&D pipeline attrition by forming a partnership with the UK’s Medical Research Council (MRC) that will see academic researchers given a shot at finding new uses for 22 AZ-developed compounds Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=724 CommonHealth: Brigham and Women’s Hospital announced today it’s been awarded $9.6 million for a new project to study how mapping patients’ entire DNA can be incorporated into actual medical practice Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=723 PharmaTimes: A new international consortium launched by a group of leading medical research funders from the UK, the US, France, Hong Kong and Singapore aims to gear up the clinical research community worldwide for a swift response to any future pandemics, epidemics or other rapidly emerging public-health threats Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=722 Mass Device: Minnesota medical device lobby LifeScience Alley signs a memorandum of understanding with the FDA, making official a year-long partnership to promote progress in regulatory science Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=721 Mass Device: The U.S. Supreme Court hears arguments ahead of its decision on whether medical information can be patented. At issue is the specter of doctors being sued for patent infringement based on treatment decisions derived from the scientific research underpinning the patent Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=720 nbsp; 9Dec11: TGA committee members must declare conflict of interest, whether financial or non-financial. 9Dec11: Consultation opens on TGA’s Risk management plan guideline. The current Guidelines have been updated to further clarify the requirements of a Risk Management Plan for sponsors and to outline the components of an Australian Specific Annex that can be included with a Risk Management Plan. Closing date: 6 January 2012. 8Dec11: Government to improve regulation of therapeutic goods. The Australian government will introduce a comprehensive package of reforms for Australias Therapeutic Goods Administration (TGA) to ensure the regulation of medicines and medical devices is more effective and transparent. 8Dec11: TGA reforms: a blueprint for TGAs future Related (just a sample of the significant commentary on these reforms): 9Dec11: GMiA response to TGA blueprint for reform. 9Dec11: Pharma Letter – blog post on the reforms and Medicines Australia’s response. 8Dec11: The conversation: TGA all bark no bite as Labor botches response to a series of reviews 8Dec11: CHF: TGA Blueprint misses key opportunities for reform 8Dec11: Medicines Australia: Medicines Australia said it was disappointing that the Blueprint for TGA’s Future, did not address the issue of different ethical standards within the therapeutics sector Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=719 Lexology: Given the widespread use of social media platforms as a means of communicating information, pharmaceutical companies need to understand the social, legal and regulatory implications of their participation in the social media environment. (must register to be able to access the article Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=718 Minister for Mental Health & Ageing: The establishment of a new national mental health consumer organisation has moved a step closer, with the Australian Government focused firmly on ensuring it will be driven by consumers, for consumers Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=717 Australian Government Treasury: The Assistant Treasurer, the Hon Bill Shorten MP, has released a consultation paper on current governance arrangements for the not-for-profit (NFP) sector. The outcomes of the governance review will help form the governance requirements for registered entities in the Australian Charities and Not-for-profits Commission legislation, starting from 1 July 2012. Closing date for submissions: Friday, 20 January Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=716 ABCOnline: Several public health groups have attacked the Federal Governments response to a series of reviews of Australias TGA. The Consumers Health Forum says the Governments response suggests its putting industrys needs ahead of consumers Mon, 19 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=715 nbsp; JCRBP, Dec11: Why I am a study coordinator – it takes passion. JCRBP, Dec11: Making Sense of Biostatistics: Standard Error vs. Confidence Interval JCRBP, Dec11: FDA Officials Detail Risk-Based Trial Monitoring PLOS Medicine, 29Nov11: What Research Is Needed to Stop TB? Introducing the TB Research Movement Platelets, 18Nov11: Drug-induced immune thrombocytopenia: A descriptive survey in the French PharmacoVigilance database. PLOS One, 16Nov11: Establishing a Minimum Dataset for Prospective Registration of Systematic Reviews: An International Consultation Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=714 Harvard Business Review: Modern-day telecommunications, the hair-trigger requirements of financial markets, and the pace of global organizations create 24 x 7 work lives for most executives. So, forget work-life balance and think personal organization and finding ways to relax Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=713 nbsp; 1Dec11: Draft Guidance for Industry - Regulatory Classification of Pharmaceutical Co-Crystals Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=712 nbsp; 2Dec11: European Medicines Agency hosts workshop on ethics in paediatric clinical trials Nov11: Updated Flow Chart for the Mutual Recognition Procedure - CMDh/081/2007, Rev Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=711 Ottosen.com: Presentation from the 3rd EMA stakeholder forum in London 20 October 11 regarding the implementation of the PV masterfile Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=710 PharmaTimes: Pharmaceutical industry groups have broadly welcomed a landmark ruling by the Court of Justice of the European Union (CJEU) clarifying the rules on extended patent protection for multi-disease products Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=709 Mass Device: Medtronic (NYSE:MDT) CFO Gary Ellis said the worlds largest pure-play device maker plans to shave at least $1.2 billion in costs from its operations, even as the company closes out a five-year, $1 billion initiative that lowered its expenses by 25 percent Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=708 AMedNews: Are patients relying on the right internet information when looking for quality doctors? More than 80% of the health rating sites that are "highly findable" when querying terms such as "doctor reports" and "hospital ratings", draw on anecdotal patient reports. Half these sites include quality information, and only a third feature cost data, according to an American Journal of Medical Quality study published in November Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=707 NY Times: Pfizer’s aggressive strategy may offer lessons for drug makers facing similar losses of patent protection for other blockbuster drugs over the next few years Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=706 PharmaPro: With imports of pharmaceuticals to the U.S. on the rise and criticism of the US FDA that it has not inspected foreign plants with any regularity, the FDA is clearly on the defensive. Likewise in Europe, member states Inspectorates are facing similar pressures of greater regulatory oversight with fewer resources. What are the implications for pharma Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=705 Genetic Engineering News: Scientists have demonstrated the feasibility of using genomic and transcriptional data resulting from integrative sequencing of tumours in a clinical setting as a means to match patients to drug trials Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=704 PharmaTimes: The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the continued commitment to public-private partnerships (PPPs) in Horizon 2020, the European Commission’s proposed €80 billion programme for investment in research and innovation Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=703 nbsp;The UK Guardian: Clinical research should be a priority in the NHS – the NHS Constitution says so. Patients, professionals working in the NHS and politicians say so, yet data suggests that clinical research is not always embedded in NHS core business. Related: The Guardian, 2Dec11, Getting involved in clinical research - A video of patients and NIHR Clinical Research Network staff talking about their experiences of being involved in clinical research; Related: The UK Guardian: UK NHS Trust research activity league tables and maps Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=702 Telegraph.co.uk: David Cameron will tomorrow announce plans to share patient records and other NHS data with private health care companies, including some that use animals in clinical tests. The UK Prime Minister will use a keynote speech to outline far closer “collaboration” between the health service and life science companies, giving them more freedom to run clinical trials inside hospitals Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=701 Xinhuanet: Cuba and China have agreed to strengthen cooperation on biotechnology. Biotechnology is now one of the most active fields of cooperation between Cuba and China. The two countries signed an agreement in September on joint development of a preventive vaccine against pertussis or whooping cough Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=700 ChinaBioToday: China has released its 12th Five-year Plan for Medical Technology, setting a long list of broad goals to be accomplished by the end of 2015. Those goals range from discovering world-leading medical technology to establishing robust means of diagnosing and treating China’s rural population, who live far from the country’s high-tech hospitals in urban centers Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=699 Xinhuanet: About a tenth of the science and technology papers included in the Science Citation Index, a leading thesis-index system, came from China in 2010, according to a recent research report Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=698 Pharmabiz: The Indian Council for Medical Research (ICMR) has come out with a new set of Draft Guidelines on Compensation for Research Related Injury in India which apply to all clinical research, whether sponsored by the pharmaceutical or medical device industry, government or academia or individual investigators. They do not apply to post marketing surveillance and ancillary care Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=697 nbsp; 1Dec11: Medicines Safety Update Vol 2, No 6, December 2011 30Nov11: A new TGA guideline about reduction of assessment fees for medical devices has been developed. 28Nov11: The TGA is seeking comments from interested parties on proposed revisions to the Australian regulatory guidelines for over-the-counter medicines (ARGOM). Responses due 11Feb Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=696 Consumer Health Forum: CHF’s submission covers a range of issues within the Code, including the nature and availability of information and claims, the relationship with healthcare professionals, the relationship with health consumer organisations, patient support programs, and abuse of the Code. CHF has also highlighted the potential role of the Code in improving the packaging and labelling of medicines and in enhancing the provision of written instructions to consumers Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=695 CIO: The National E-Health Transition Authority (NEHTA) has licensed software from the Commonwealth Scientific and Industrial Research Organisation (CSIRO) to aid the move to a standardised dictionary of clinical terms as part of the Federal Government’s Personally Controlled Electronic Health Record (PCEHR) project Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=694 DoHA: Professor Elizabeth Blackburn’s stellar international career, which includes the Nobel Prize for Medicine in 2009, has inspired the NHMRC to recognise the next generation of Australian women in science. The inaugural Elizabeth Blackburn Fellowships were awarded to: Assoc Prof Amanda Leach (Menzies School of Research), Assoc Prof Christine Roberts (University of Sydney), and Prof Carola Vinuesa (John Curtin School of Medical Research Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=693 Australian Life Scientist: In support of the work of the Clinical Trials Action Group (CTAG), the Federal Government is conducting a first-of-its-kind study to gauge the level of privately funded clinical research activity in Australia. The Government is calling on companies from the pharmaceutical, biotechnology, med-tech and IVD sectors as well as CROs working on clinical trials to participate in the study. Responses are requested by 5:00PM, Tuesday, 13 December 2011 and the report due by Q Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=692 GMiA: Generic medicines continue to drive important savings to the PBS. The original budget forecast of savings of $1.9 billion over 4 years represents significant savings and the actual savings are likely to be greater than this Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=691 DoHA: Australians can now look back at over three-years of elective surgery and emergency department data for their local hospital on the popular MyHospitals website following new data added to the website on 30 November Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=690 Medicines Australia: The latest Commonwealth Department of Health and Ageing’s annual review of the Pharmaceutical Benefits Scheme shows that the program grew by just 5.2 per cent in 2010-11 – or 1.6 per cent in real terms Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=689 DoHA: An article published by The Australian newspaper today (The Australian, 1/12/11, p.7) suggests the Federal Government has “manipulated” and interfered with the National Health and Medical Research Councils (NHMRC) Literature Review process. The Minister for Mental Health and Ageing responds to the claims Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=688 Australian Life Scientist: AusBiotech will be lobbying for a greater emphasis on biopharma and medical devices on the newly established Prime Ministers Taskforce on Manufacturing Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=687 DoHA: More than 160,000 patients will benefit directly from changes to the Pharmaceutical Benefits Scheme (PBS) from today, including patients being treated for cancer, HIV and chronic obstructive pulmonary disease Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=686 DoHA: The Minister for Indigenous Health, Warren Snowdon, has had no choice but to shave off his trademark moustache after Queensland’s peak Aboriginal and Torres Strait Islander health body raised $10,000 for Movember Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=685 NHMRC: The brightest minds in science have gathered in Canberra over the last three days to discuss the best way forward to translate research into proven health outcomes that ensure a healthy future for all nations Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=684 NHMRC: Australia’s top researchers are being honoured at the National Health and Medical Research (NHMRC) annual awards ceremony in Canberra tonight. Minister for Mental Health and Ageing, Mark Butler congratulated the 19 award winners including recipients of the Achievement Awards and the inaugural recipients of the Frank Fenner Early Career Fellowship and Marshall and Warren Award Fri, 09 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=683 The ONHMRC has recently released the Research Governance Handbook: Guidance for the national approach to single ethical review. A pdf document is currently available of the Human Research Ethics Portal at http://hrep.nhmrc.gov.au/toolbox/guidance-multi-centre-researchA desktopped version will be released in the coming weeks Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=682 Nov11: Guidance for Industry - Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=681 Nov11: The European Medicines Agency is inviting pharmaceutical companies to register to take part in a three-month pilot of its eSubmission Gateway, beginning on 9 January Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=680 Mass Device: The Global Harmonization Task Force (GHTF) continues to issue guidances likely to influence major medical device regulators worldwide Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=679 Genetic Engineering & Biotechnology News: As genomics starts to inform proteomics and personalized medicine, it’s going to take massive amounts of computer power for storage capacity, data management, and analysis. The amount of data generated could reach the petabyte range (equal to 1 billion megabytes). The petabyte crisis and the need to use all that data to discover novel therapeutics provide ready-made forcing functions to move companies into the cloud Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=678 The Guardian (UK): A report by Deloitte on the worlds 12 largest drugmakers shows that the average cost of bringing a product to market rose by more than 25% to more than US$1bn this year, from US$830m in 2010. The number of late-stage drugs in development dropped to 18 from 23, on average, per company. Ten of the 12 firms have seen a decline in returns from R&D, resulting in an overall drop to 8.4% from 11.8% last year Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=677 AMedNews: The impact of public research funding at US medical schools and teaching hospitals contributes an estimated $45 billion to the U.S. economy each year, $17.3 billion in direct spending and $27.6 billion in indirect economic benefits such as spending by researchers, staff and visitors, according to a Nov. 7 Assn. of American Medical Colleges report. Every dollar invested in research at medical and teaching schools results in $2.60 of economic activity, the report said Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=676 BNA.com: Three former executives at medical device manufacturer Synthes Inc. were sentenced to prison Nov. 21 for their roles in conducting clinical trials of bone cements without Food and Drug Administration approval Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=675 WorldPharmaNews: Pfizer Inc. will acquire Excaliard Pharmaceuticals, Inc., a privately owned biopharmaceutical company focused on developing novel drugs for the treatment of skin fibrosis (skin scarring). The acquisition is expected to close before the end of the year Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=674 Outsourcing pharma: Spinning-out assets to form a CRO can help large biopharm commercialise knowledge and focus on core activities, research found Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=673 Inpharm Regulatory authorities around the world are recalling cancer drugs manufactured by Boehringer Ingelheims Ben Venue Laboratories subsidiary after an inspection uncovered quality problems at its manufacturing facility in Ohio, USA Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=672 Outsourcing Pharma The Hong Kong DH has become the latest regulator to take action against products manufactured by Ben Venue Laboratories Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=671 Centerwatch: RaySearch Laboratories has entered into an exclusive distribution agreement with the South Korean distributor Oncology Total Solution, based in Seoul. The agreement means that OTS will be fully responsible for marketing, sales and service for RaySearch’s proprietary treatment planning system RayStation on the South Korean market Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=670 ChinaBioToday: China will invest 10 trillion RMB ($1.7 trillion) over the next five years into five strategic industries – one of which is biotechnology. (Full article available upon payment Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=669 ChinaBioToday: Lilly remains worried about IP theft in China, even though the company is upping its investment in the China market in an attempt to increase its market share Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=668 Xinhuanet.com: The number of Chinese diabetes patients nearly doubled over the past decade, with 9.7 percent of the countrys 1.3 billion people suffering from the disease, according to a Chinese medical expert Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=667 Pharmatimes.com Many medical publication professionals are aware of unpublished negative data from clinical trials and many believe obligations to make these data available should go beyond current legal requirements in the US and the EU, a new survey has found Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=666 Harvard Business Review Blog: Creativity and innovative thinking are not genetic traits. What makes people great innovators is not their genetic makeup, but a set of skills and behaviors. The good news: anyone can learn, practice, and master the skills necessary to become a disruptive innovator Trials, 23Nov11: Why we need easy access to all data from all clinical trials and how to accomplish it Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=665 DoHA: Transcript of Minister Roxon’s address to the Press Club. Related: Transcript of National Press Club 22Nov11 Q&A Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=664 Nine News: Australias drugs regulator is facing calls to overhaul the system of medication warnings for pregnant women amid claims it is outdated and confusing. Because of the confusion, many pregnant women put their health at risk by not taking medication despite there being little chance of harming their unborn babies Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=663 DoHA: Address by Hon Catherine King MP, Parliamentary Secretary for Health and Ageing to the Pharmacy Guild of Australia Annual Parliamentary Dinner Great Hall, Parliament House, Canberra, 21 November Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=662 DIISR: A joint Australian-French symposium on biomedical research collaboration in Canberra will focus on increasing researcher exchanges and enhancing research and training opportunities on health sciences and biomedicine Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=661 Herald Sun: Health Minister Nicola Roxon is open to the idea of a parliamentary inquiry into the Federal Governments $15 billion agreement with pharmacies on how medicines are distributed. But Ms Roxon insists Labor wont consider scrapping the five-year deal with the Pharmacy Guild, which started in mid Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=660 Medicines Australia: A discussion paper released by Medicines Australia describing and demonstrating the value of clinical trials, and the need to continue improving Australia’s environment for clinical trials. Related: Media release Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=659 DoHA: Legislation has been introduced into Parliament for Australia’s national eHealth records system, with the rollout starting from July Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=658 DIISR: Providing patent protection for innovators and researchers – while ensuring reasonable access to new technologies and medical treatments – are the key aims of the Government’s response to three important reports into Australia’s patent system and gene patents Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=657 Australian Life Scientist: The Senate Standing Committees on Community Affairs has completed its Inquiry into The Regulatory Standards for the Approval of Medical Devices and tabled its report in the Senate on Tuesday night Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=656 World Dental: The Australian Dental Industry Association (or ADIA) strongly supports the recommendations coming from the Senate Committee according to which the importation of dental products needs more regulations Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=655 NHMRC: The brightest minds in international health and medical research will gather in Canberra next week at a scientific symposium to discuss the global health challenges facing this generation and the next. Research for a Healthy Future (November 29 – December 1) forms part of the NHMRC’s 75th anniversary program Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=654 DIISR: In a major medical breakthrough, an Australian company has developed the world’s first commercial 3D bioprinter, helping organisations working on tissue construction and organ replacement Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=653 Medicines Australia: The Federal Government’s support for the patenting of genetic materials should enable patients to continue enjoying access to biological medicines, the chief executive of Medicines Australia Dr Brendan Shaw said today Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=652 DoHA: The Australian Government will reform Australia’s childhood immunisation arrangements with the aim of increasing the immunisation rates of Australian children over time. Related: Crikey 25Nov11The Federal Government has announced a major shake up to the way vaccination is linked to financial incentives, which will begin taking effect from July Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=651 Medicines Australia: Research published this week in The New Zealand Medical Journal, found that New Zealanders have access to less than half the number of prescription medicines that Australians can access Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=650 nbsp; 25Nov11: Classification of IVD medical devices – Updated guidance v1.1 24Nov11: Update from the external reference group regarding the labelling and packaging review 24Nov11: What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs 22Nov11: Presentations about manufacturing therapeutic goods – added Sep presentations on GMP audit trends and observations Thu, 01 Dec 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=649 Harvard Business Review: A recent American Psychological Association (APA) survey found that 48% of employees do not feel valued at work. So, although companies often tout the importance of their people, the everyday experience of many doing the work is something quite different. If people are to be fully engaged at work, they must first have meaningful work to do. For employees to stay fully engaged, their inner work lives must be consistently nourished with respect, recognition, and encouragement. BMJ Editorial, 7Nov11: Why do the results of randomised and observational studies differ? [Full article only available to BMJ subscribers] Applied Clinical Trials, 1 Nov 11: eClinical: A Yellow Brick Road? Examination of eClinical shows that it is more than just bold claims, there is substance Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=648 NY Times: As much as we would like to think that, put on the spot, we would do the right — and perhaps even heroic — thing, research has shown that that usually isn’t true Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=647 nbsp; 17Nov11: Final Guidance - Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=646 NY Times: The company conducting the world’s first clinical trial of a therapy using human embryonic stem cells said on Monday that it was halting that trial and leaving the stem cell business entirely Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=645 Pharmalot: When doctors and researchers sign up to participate in a clinical trial, they are expected to do a few basic things. Among them is keeping up to date with the clinical trial doings. One way to accomplish this is to open the mail. But not everyone does. As a result, one investigator was forced to admit that she had no idea what was going on. And the FDA did not like this one bit Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=644 InPharm: During 2011, the National Institute for Health Research Clinical Research Network launched a number of new initiatives to support pharma companies and CROs in delivering research studies in the NHS. Dr Jonathan Sheffield, chief executive of the NIHR Clinical Research Network, examines these latest developments, and what they could mean for timely commercial study delivery Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=643 PharmaTimes: GSK has launched a $50 million investment fund to support early-stage breakthrough research in Canada. Managed by GSK in Canada and GSK’s global corporate venture capital arm, SR One, the GSK Canada Life Sciences Innovation Fund will look for strategic investment opportunities in the Canadian life sciences sector, including academic and health institutions, translational research centres and start-up companies Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=642 Pharmalot: Pfizer has reached an agreement in principle with the US Department of Justice and the US Securities and Exchange Commission to resolve a foreign bribery investigation. The disclosure comes three months after Pfizer said it “voluntarily” provided the agencies with information about “potentially improper payments” made by unspecified Pfizer and Wyeth subsidiaries in connections with sales activities in countries other than the US Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=641 Sacramento Bee: goBalto, developer of new generation web-based clinical research solutions, announced that it is providing a research grant for the Tufts Center for the Study of Drug Development (Tufts CSDD) to benchmark the clinical trial initiation process. Fifteen biotechnology and pharmaceutical companies and CROs will provide data on their experience initiating clinical trials Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=640 Medical Observer: THE federal government has taken another step towards setting up its patient-controlled electronic health records (PCEHRs) system, with Health Minister Nicola Roxon introducing the legislation to Parliament yesterday Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=639 Nov 2011 - A Senate committee has demanded urgent action from health authorities who allowed faulty hip implants to be used in more than 5,000 patients. Related ABC– 23 Nov 2011 – Senate demands action on faulty hip replacements Australian Healthcare & Hospitals Association 23 Nov 2011 - Xenophon says the Therapeutic Goods Administration has failed Australians MTAA Statement 23 Nov 2011– Statement regarding the Senate Report Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=638 nbsp; 18Nov11: The regulation of medical devices Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=637 MJA Editorial: The advice of community pharmacists in response to customers’ enquiries is widely relied upon, but events in the past few months raise serious questions about the trustworthiness of some in the profession Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=636 Medical Observer: MORE than 1300 complementary medicines face being struck off the therapeutic goods register because their owners have failed to pay annual listing fees – totalling $701,000 – to the Therapeutic Goods Administration (TGA Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=635 Commonwealth Parliamentary Library: The paper provides an introductory overview of some of e health’s critical aspects. In so doing, it looks briefly at certain aspects of the overseas experience of e health policy development and considers some practical application case studies. For the most part, however, the paper concentrates on the evolution of e health policy in Australia Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=634 MSN India: India today sought easy market access for Indian pharmaceuticals in Australia where they are facing problems in getting approvals Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=633 Australian Life Scientist: The new AAHL Collaborative Biosecurity Research Facility (ACBRF) in Geelong is one of the world’s most advanced bio-secure laboratory, and it was officially opened for business today Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=632 Sydney Morning Herald: Medicines sold over the counter will be subjected to tougher scrutiny after several government reviews spurred by mounting criticism over the promotion of unproven remedies. The federal government is likely to announce within weeks a revamp of the Therapeutic Goods Administrations regulation of new remedies Fri, 25 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=631 SmartBlog: A question-and-answer session with Maddie Grant and Jamie Notter, co-authors of “Humanize: How People-Centric Organizations Succeed in a Social World.” Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=630 Harvard Business Review Blog: One of the most common complaints about leaders is that they are promoted for their technical skills, and often have poor social skills. A big insight that emerged on day two of the 2011 NeuroLeadership Summit is that this may simply be a function of the leaders role Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=629 nbsp; 10Nov11: FDA approves first cord blood product - HEMACORD, the first licensed hematopoietic progenitor cells-cord (HPC-C) cell therapy. 10Nov11: FDA issues two draft guidance documents to facilitate investigational medical device studies in humans – one draft guidance aimed at fostering early-stage development of medical devices within the US and the second a guidance regarding clinical trials and medical devices Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=628 PPD: In our new white paper, we detail the recent advancements and remaining challenges in Chinas regulatory environment and expanding clinical trial infrastructure Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=627 Japan’s PMDA: Links to presentations from this workshop, held 1-2 Nov in Japan to promote multi-regional trials in the Asia-Pacific region Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=626 CentreWatch: Five months after INC Research’s acquisition of Kendle International closed, executives from the now-combined CRO are landing jobs with competitors Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=625 Health Canada: The Guidance serves to assist sponsors in seeking authorization from Health Canada to conduct a clinical trial with a drug (pharmaceutical and/or biologic and radiopharmaceuticals) in human subjects pursuant to Part C, Division 5 of the Food and Drug Regulations. This guidance document clarifies application and post-authorization requirements and procedures. This consultation is open for comment until February Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=624 UK’s NICE: NICE has today published a new clinical guideline on best practice for the diagnosis and treatment of people with colorectal cancer. The guideline will help health professionals to provide consistent care for patients with colorectal cancer, supporting patients with the disease and ensuring equal access to services across England and Wales Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=623 Pharmaceutical Technology: The release of new legislation on pharmacovigilance in December 2010 has set off one of the biggest transformations in the European pharmaceutical industry since the introduction of the European Medicines Agency (EMA) itself. Elisabeth Fischer speaks to Heiko Martin, head of global drug safety at Grünenthal, about implications for detecting and preventing adverse drug reactions Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=622 Mass Device: Med-tech makers could see an earlier payoff by looking at ways to deliver drug therapy with their devices, MIT researcher Michael Cima says Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=621 NICE: NICE has today opened a consultation on new draft guidance on identifying people at high risk of developing type 2 diabetes and the provision of clinically and cost effective interventions to help reduce the risk or delay the onset of the condition. The draft guidance is available for comment until Monday 9 January Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=620 Mass Device: From biology lab leaders to the U.S. Surgeon General, theyve all convened to share, to educate and to think. Art, sensing technology, mobile devices, biology and on and on are merging to create solutions to an uncountable number of health care problems. Why doesn’t this thinking happen every day Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=619 InformationWeek Healthcare: Dell Computer is partnering with several hospitals, the National Cancer Institute, and researchers, in a cloud computing project aimed at helping scientists and clinicians develop more personalized and effective medical treatments for kids with cancers. The new personalized medicine clinical trial project initially is focused on neuroblastoma, a rare, deadly cancer Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=618 US Institute of Medicine: On July 19, 2011, the IOM’s Roundtable on Translating Genomic-Based Research for Health hosted a workshop to highlight and identify the challenges and opportunities in integrating large-scale genomic information into clinical practice. The main objective of the workshop was to start a discussion on what needs to be done to prepare the necessary infrastructure and to address the various challenges for realizing genomic medicine. This document summarizes the workshop Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=617 RebarInteractive: Boehringer has been watching the rise of healthcare gamification. They recently announced the upcoming release of a new Facebook game called Syrum, which will allow players to save the world by combating one disease at a time. Boehringer will primarily use Syrum for brand purposes. Though players will run clinical trials as part of the game, it’s not clear whether Boehringer intends to incorporate significant educational components into this game stage Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=616 Pharmabiz: India’s clinical trial industry is annoyed over the continued delay in giving approvals for the clinical trials, including the bioavailability and bioequivalance (BA/BE) studies, by the DCGI, ever since the controversy surrounding the Hyderabad-based CRO Axis Clinicals hit the headlines Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=615 Pharmalot: In fiscal year 2010, the agency conducted 792 inspections. There were 400 inspections of trial investigators, 77 percent were the result of audits, with the rest due to complaints or referrals. By the way, 116 international investigators were inspected. 10 percent of the inspections were in Asia and the Pacific region Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=614 TrialX CureTalk: Time to disease progression refers to how long it takes for a patient’s cancer to return after they start using a therapy. Median life expectancy measures how long a patient lives after beginning therapy. In other words, how long will the patient live if they use a particular therapy Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=613 nbsp; 10Nov11: November 2011 issue of the Prescription Medicines Business Process Review newsletter 9Nov11: TGA eBS Notices email list. This email service notifies subscribers of changes to the IT systems and services that may impact their conduct of business with TGA, including interruptions to service because of scheduled maintenance. Consultations on adoption of EU guidelines in Australia - The closing date for submissions on adoption/non-adoption of a number of EU Guidelines has been extended to 18 Nov Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=612 DoHA: The Australian and Victorian Governments have agreed on the implementation plan to develop the $1 billion Victorian Comprehensive Cancer Centre. Minister for Health and Ageing Nicola Roxon welcomed the agreement that will see the Gillard Government provide $426 million towards the billion dollar Centre Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=611 DIISR: Through the Australian Governments Inspiring Australia initiative, $500,000 is available for grants of between $2,000 and $25,000 for an individual one-year project, for the first time and, grants up to $75,000 are also available for large projects over three years. Applications close at 5pm on 28 November Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=610 ABC Science: Ian Chubb, Australias Chief Scientist, argues that scientists are an unappreciated force for good in Australian society Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=609 ABC 7.30 Report Vodcast: A Senate report into an orthopaedic medical scandal prompts questions over the regulation of Australias medical devices industry Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=608 Invest in Australia: The Australian Customs and Border Protection Service and the Therapeutic Goods Administration (TGA) took part in September in an international ‘Week of Action’involving 80 couuntries, targeting the online sale of counterfeit and illegal medicines. Operation Pangea IV has resulted in a series of arrests across the globe and the worldwide seizure of thousands of potentially harmful medical products Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=607 DIISR: New therapeutic approaches to multiple sclerosis, diabetes, stroke and heart disease may be discovered at the new $21 million Stem Cells Australia research initiative, led by internationally-renowned stem cell researcher Professor Martin Pera from the University of Melbourne Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=606 Australian Medicines Industry: Anyone who’s experienced a benefit from medicines, from antibiotics, to chemotherapy, asthma medication to common painkillers and everything in between, is urged to share their story at www.medicinememories.com.au before early December, when the information will be handed over to the National Library Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=605 ABC Online: Negotiations on a plan for a free trade agreement between nine countries, including the US, Australia and New Zealand have been going since March last year. They were meant to be completed at the APEC meeting but theyve essentially been delayed because of US demands which are far more extreme in the areas of medicines particularly and intellectual property Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=604 NineMSN: Further cuts to the PBS Scheme risks threatening the best subsidised medicines scheme in the world, the pharmaceutical industry has warned Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=603 DIISR: Announcing the $248 million in funding for 480 talented researchers through the 2011 Australian Research Councils Future Fellowships and Discovery Early Career Researcher Awards (DECRA) schemes today, Innovation Minister Senator Kim Carr said the funding was helping Australia grow its vital research workforce and keep Australias researchers on the path to discovery Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=602 DoHA: Funding for health and ageing grants programs will be easier to access with a new, simpler system that opened today. A strategic review of the administrative arrangements in the health and ageing portfolio last year recommended consolidating 159 smaller programs into 18 larger, flexible funds. Over time, the new system will enable the majority of grant holders to move to a single agreement with the department, reducing their administrative and reporting burden Wed, 16 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=601 Harvard Business Review: Asking questions is an essential skill of a great boss. Yet many fail to inquire enough. Here are three types of questions you should be asking Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=600 Nov 11: FDA - 35 innovative new drugs approved in fiscal year 2011 2 Nov 11 (via Mass Device): The FDA wants input from the health care industry and the public on the efficacy of its medical device labeling system. The federal watchdog agency is opening up a 60-day public comment period, slated to end Jan 3, 2012, on the med-tech labeling system. 1 Nov 11: Guidance for Industry – ICH Q8, Q9, and Q10 Questions and Answers Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=599 nbsp; 4 Nov 11: European and international experts discuss the way forward in developing ophthalmology medicines. On 27 and 28 October 2011, the European Medicines Agency assembled for the first time some 200 experts in eye diseases from Europe, Australia, Japan and the United States of America in a two-day workshop. The attendees reviewed regulatory and scientific challenges in developing medicines for eye disorders Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=598 BioScholar via Ausbiotech: Dietary and lifestyle differences may explain why South Asians and Europeans require different doses of drugs to treat similar conditions. Vidya Perera, final year pharmacy doctoral student at the University of Sydney, has found that people from South Asia could manage with lower drug doses because of lower levels of CYP1A2, an enzyme that metabolises drugs Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=597 iWatch: Making electronic record-keeping systems easier for health providers to use can help prevent dangerous or even fatal mistakes, says the draft of a project by the US National Institute of Standards and Technology (NIST). The draft, titled “Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records,” provides guidance for testing electronic health record-keeping systems to make sure they are understandable for health care practitioners Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=596 JCRBP: According to a recent survey from William Blair, about 80% of big pharma companies either are in the process of restructuring or have already completed restructuring plans to strategically outsource more of their trials to CROs Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=595 WHO Bulletin: Public health organizations are starting to use social media.Some specialists say they hold untapped potential for public health. The WHO and US CDC use social media, but other organisations are not so advanced. This article discusses the challenges and opportunities Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=594 UK MHRA: MHRA has launched a new Agency discussion forum for Good Clinical Practice (GCP) that provides the ideal opportunity for extended communication between researchers and allows users to put forward their comments and get real-life examples Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=593 PharmaTimes: Regional pathways for the regulation and ethical review of clinical trials, coupled with new processes for the design and conduct of faster, cheaper and more effective studies, are imperative if the growing pipeline of drugs and vaccines for neglected diseases is to deliver viable products to patients in need, a new report from the US-based Center for Global Development insists Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=592 BBC News: The pair, who ran Euroderm Research and were accused by the MHRA of fabricating test results for two clinical trials, one of them for childrens medication, between July 2006 and June 2007 have been cleared of all charges Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=591 Eurekalert: An article published in the Nov. 2, 2011 issue of Nature explains why this virus spreads so rapidly. Measles virus spreads from host to host primarily by respiratory secretions. This mode of transmission explains why the virus spreads so quickly and how it resists worldwide vaccination programs to eradicate it Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=590 Pharmalot: Partnership to Advance Clinical Electronic Research, or PACeR, is a collaboration between five large drugmakers, 13 hospitals across New York, CROs, health information technology companies and regulators. The drugmakers will pay PACeR up to $200,000 to sift through the records of the hospitals to find patients whose profile would fit the criteria for a trial Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=589 PharmTech Blog: With 2011 sales of approximately $54.1 billion, Pfizer currently holds the crown as the world’s largest drugmaker, but next year may see the pharma giant usurped from its throne by Sanofi and Novartis, who will claim pole and second position respectively in the global pharmaceutical rankings Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=588 nbsp; 5 Nov 11: International Medical Device Regulators Forum (IMDRF). On 6-7 October 2011, representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and United States, as well as the WHO, met in Ottawa to address the establishment and operation of a new organisation, the International Medical Device Regulators Forum (IMDRF) to help harmonise medical device regulation. 4 Nov11: The TGA structure explained Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=587 NSW MoH: The latest output from the NSW Health and Medical Research Strategic review – the Discussion Paper – has been released. Feedback is due by 5pm 16 November Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=586 DIISR Media Release: The department is seeking feedback in response to the consultation paper: Defining Quality for Research Training in Australia and is holding public information sessions to seek your views Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=585 DIISR Media Release: Better treatment for cancer, improved communication in hospitals and tackling obesity in families at risk are likely to flow from the Gillard Labor Government’s $310 million investment in research. Announcing funding for over 1,000 national research projects as part of the Australian Research Council’s 2012 Major Grants Announcement, Innovation Minister Senator Kim Carr said the Government was encouraging health research to secure a healthier future for all Australians Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=584 Sydney Morning Herald: Keith Petrie, a New Zealand academic who has researched what stops patients taking their medicine, says just as an increasing number of people are dependent on life-saving drugs to keep their chronic illnesses at bay there appeared to be an increasing suspicion about modern drugs Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=583 Australian Life Scientist: A 50/50 joint venture with Japanese Otsuka Pharmaceutical Factory has injected $25 million into the company which was running perilously short on cash Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=582 DoHA Media release: A key pillar of the Australian Government’s health reforms, the Independent Hospital Pricing Authority, has moved a step closer with legislation to establish the statutory authority passing the House of Representatives Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=581 Medicines Australia: The medicines industry will offer Australia significant strategic and economic advantages in a post-mining boom future with the right policy settings to encourage innovation, research and manufacturing, Medicines Australia chief executive Dr Brendan Shaw told the National Press Club today Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=580 Minister for Mental Health & Ageing Media Release: A new online mental health app designed specifically for young men was launched for trial on 3 November 2010 by the Minister for Mental Health and Ageing, Mark Butler Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=579 DIISR Media Release: Australia’s Chief Scientist, Professor Ian Chubb AC, will lead a new committee to guide Australian Government research investment, ensuring it meets the nation’s strategic priorities and delivers long-term prosperity and security. Releasing the Focusing Australias Publicly Funded Research Review, Innovation Minister Senator Kim Carr said the Labor Government had increased its support for research, science and innovation since taking office by 43 per cent to $9.4 billion this financial year Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=578 Medicines Australia: AMGEN, CSL and GlaxoSmithKline have been nominated as finalists for the 2011 Business Achievement Awards conducted by the Equal Opportunity for Women in the Workplace Agency Thu, 10 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=577 nbsp; 26Oct11: FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation. The centers, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernize and improve the ways drugs and medical devices are reviewed and evaluated, a major focus within the FDA. 19Oct11: Draft Guidance: E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility NY Times:27 Oct 11 Teaching Doctors to Be Mindful There has been a growing awareness among doctors that being mindful, or fully present and attentive to the moment, not only improves the way they engage with patients but also mitigates the stresses of clinical practice. Aus School of Business:25 Oct 11The Entrepreneurs Big Question: Could Steve Jobs Have Succeeded in Australia?Australia may be producing many technological talents, but what needs to change Down Under to ensure, like Jobs, their creativity survives and thrives? A group of experts for an upcoming event have convened to figure this out. Aus School of Business:25 Oct 11On the Career Fast Track: Why Some People Learn Faster By understanding more about the way people learn and work, organisations may be able to boost their performance. This article provides some insights into the learning process. 26Oct11 Trials: Collaborative research between academia and industry using a large clinical trial database: A case study in Alzheimers disease 26Oct11 Trials: Investigating a training supporting shared decision making (ITS SDM 2011): study protocol for a randomized controlled trial 25Oct11 BMJ: Experts criticise industry sponsorship of articles on health policy in Australian newspaper [Article only available to BMJ subscribers] Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=576 CentreWatch: Over the last 10 years, the top nine global CROs have more than doubled their workforce, which now exceeds 72,000 employees, and their revenues have increased at a compound annualized rate of 11% according to an ACRO member survey Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=575 UK MHRA: Consultation ML X375 seeks your views on the draft consolidated medicines regulations and proposed policy changes to ensure that medicines legislation remains fit for purpose and reflects modern practice Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=574 PharmaTimes: A growing number of clinical trial sponsors, and particularly those from the commercial sector, are relying on the Voluntary Harmonisation Procedure (VHP) introduced in 2009 to streamline the assessment of multinational trial applications across the European Union, a regulatory affairs meeting in Italy heard recently. Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=573 The Pharma Letter: To contribute to an informed debate, the biotech trade group EuropaBio is launching a new brochure acknowledging the complexity of biotechnology-derived medicines (which are also referred to as biological medicines) and the emergence in Europe of a new category of biotech medicines: biosimilars Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=572 nbsp; 31Oct11: Improving international cooperation between regulators. The TGA, the EMA, and the US FDA have completed a pilot program designed to enhance information sharing and cooperation on the inspection of manufacturing plants producing active pharmaceutical ingredients. 28Oct11: Cancellation of a therapeutic good for non-payment of an annual charge. An explanation of the process Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=571 The Australian: Pharmaxis expects to begin marketing its key cystic fibrosis drug, Bronchitol, early next year, after the European Medicines Agency reversed its view of the product and recommended it be used in adults as an additional therapy to the best standard of care Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=570 The AustralianIT: The teams expected to draft and complete new technical specifications for the $500 million personally controlled e-health system by November 30 are yet to hold their first meetings Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=569 Medicines Australia: A consortium of pharmaceutical companies working with NGOs to combat the rise of HIV/AIDS in Papua New Guinea has won the 2011 Pat Clear Award – the Australian medicines industry’s most prestigious accolade Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=568 Medicines Australia: A new voluntary database to enable the sharing of intellectual property for R&D on medicines and vaccines will encourage the development of new medicines and vaccines to combat neglected tropical diseases according to Medicines Australia chief executive Dr Brendan Shaw. WIPO Re:Search was launched in Geneva by the World Intellectual Property Organisation Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=567 Scoop.co.nz: Leaked proposals for the Trans Pacific Partnership (TPP) Agreement confirm United States (US) efforts to undermine access to medicines in Australia and the Pacific, according to the Public Health Association of Australia (PHAA) and the Australian Fair Trade and Investment Network (AFTINET Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=566 DoHA Media Release: Topics include Health Reform, Private Health Insurance Rebate, MBS, Telehealth, NBN, After Hours GP Helpline Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=565 The AustralianIT: The government-owned National Health Call Centre Network is positioning itself as a lead player in Australias e-health space through the provision of software-based medical triage and health information services delivered over the web or by phone Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=564 Crikey Blog: Adam Cresswell, the health editor at The Australian, responds to recent comments at Crikey and Croakey, about the newspaper’s Health of the Nations series that was sponsored by Medicines Australia Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=563 GMiA Media Release: The Generic Medicines Industry Association has its Code of Practice review for 2011. The Board is pleased to adopt the recommendations from the review and has agreed that Members of GMiA will provide a yearly statement declaring their compliance with the GMiA Code of Practice Tue, 01 Nov 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=562 nbsp; PLOS Medicine: Educating a New Generation of Doctors to Improve the Health of Populations in Low- and Middle-Income Countries. Harvard Business Review How Great Companies Think Differently: This article turns the spotlight on a different logic - social or institutional logic - which lies behind the practices of many widely admired, high-performing, and enduring companies. In those firms, society and people are not afterthoughts or inputs to be used and discarded but are core to their purpose Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=561 Orphan Drug Regulations. The FDA is proposing to amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. Comments on the proposed rule are due by by January Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=560 nbsp; 21Oct11: European Medicines Agency starts new review of cardiovascular risks of non-selective NSAIDs 21Oct11: European Medicines Agency clarifies opinion on pioglitazone and the risk of bladder cancer 20Oct11: European Medicines Agency concludes that benefit-risk balance of angiotensin II receptor antagonists remains positive Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=559 Bloomberg: The Abbott Park, Illinois-based company Abbott Laboratories said yesterday it will split next year, with one company selling medical products and the other prescription medicines. The breakup into two companies will create a prescription-medicine spinoff that may become a $54 billion target for drugmakers looking to rejuvenate their flagging portfolios Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=558 Wichita Business Journal: A Kansas physician and a researcher have pleaded guilty to pleaded guilty to one count of conspiracy and one count of failing to maintain records in a clinical trial they were paid to conduct Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=557 PharmTech Talk: The Court of Justice of the EU ruled on Oct. 18, 2011 that “A process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented.” Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=556 PharmaTimes: A user guide outlining standardised data elements to help pharmaceutical companies and medical researchers collect, pool and compare data from clinical trials for Alzheimer’s disease has been released by the US-based Critical Path Institute (C-Path) and the Clinical Data Interchange Standards Consortium (CDISC Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=555 nbsp; Labelling and packaging review. Update regarding the review Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=554 MJA: The 2010 winter saw an excess of serious adverse events linked to the CSL influenza vaccine. With another influenza season over, the MJA investigates what progress has been made to ensure it does not happen again Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=553 NHMRC: The Minister for Mental Health and Ageing, Mark Butler, today announced the single largest investment in grants for health and medical research in Australian history. The Gillard Labor Government is providing $673.7 million for 1,140 grants to support researchers, research projects and research institutions Australia-wide. Related: All NHMRC’s press releases describing grant successes, 17 Oct Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=552 ABC News in Science: In Australia, medical measuring instruments such as sphygmomanometers are approved for sale by the TGA on the basis of data submitted by the manufacturer. But there is no requirement for them to be checked once they are sold. Dr Martin Turner, a research fellow from the University of Sydney, says the problem is, these devices are subject to stresses that can render them inaccurate over time Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=551 AAP: Australias drug regulator says it knew in 2009 that drug maker CSLs seasonal flu vaccine caused higher rates of fever than other brands, but no action was taken because the fevers were mild and moderate Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=550 The Australian: GlaxoSmithKline is leading a push to have drug companies name the doctors they pay to promote drugs as a national code of conduct comes up for review Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=549 WA Today: The TGA is demanding an urgent explanation from the Pharmacy Guild and Pfizer over payments to pharmacists for enrolling patients who have been prescribed Pfizer products. The action has come as it emerges there may be at least 18 similar patient support programs under which pharmacists and other health professionals are paid a fee by drug companies to sign patients up to programs that enable drug companies to communicate health messages directly to patients. Related: Medicines Australia, 21 Oct 11: Patient support programs play a key role in health Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=548 Aus Health IT Blog: Selected sections relating to e-health from the Committee meeting Thu, 27 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=547 Medicines Australia Media Release: According to ABS figures released today, the medicines industry attracted $1.002 billion in R&D investment in 2009-10. The medicines industry’s R&D investment was the third largest by area of business expenditure, behind financial services and mining. Related: 11Oct11: ABS summary statistics on Research and Experimental Development (R&D) undertaken by Australian businesses during 2009-10 – Report Wed, 19 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=546 Australian Life Scientist: The growth of China’s life sciences sector presents tremendous opportunities for Australian biotechs, but it pays to understand the nuances of the culture and take things slow Wed, 19 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=545 The Australian: A full bench of the Federal Court has overturned a decision against one of the worlds biggest pharmaceutical manufacturers, finding that while the drug Vioxx might have had a "defect", it could not be proved to have caused a particular heart attack Wed, 19 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=544 Australian Life Scientist: An overview of the life scientist industry in South Australia Wed, 19 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=543 ABC News: A former pharmaceutical saleswoman has told the ABC she regularly paid senior Australian doctors to deliver promotional presentations to other doctors about new drugs. Medicines Australia says the pharmaceutical industry is considering greater transparency as part of a review of its code of conduct. But the AMA has strongly defended doctors who accept hospitality or speaking fees from drug companies Wed, 19 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=542 NSW Health Minister’s speech to the Australian Financial Review Wed, 19 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=541 The Age ONE of the worlds biggest drug companies has been accused of paying Australian pharmacists kickbacks to promote some of its drugs in a controversial deal that has divided the profession Wed, 19 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=540 nbsp; 7 Oct 11: Pilot Program for Parallel Review of Medical Products: The FDA and the Centers for Medicare and Medicaid Services (CMS) are soliciting nominations from sponsors of innovative device technologies to participate in a pilot program for concurrent review of certain FDA premarket review submissions and CMS national coverage determinations. 6 Oct 11: AHRQ - Assessing Equivalence and Non-Inferiority - Draft report available for comment by 2 Nov. Report discusses the difference between “equivalence” trials (EQ) and “non-inferiority” (NI) trials and issues relating to their use and interpretation. 4 Oct 11: FDA outlines plans for an outside network of scientific experts. FDA’s Center for Devices and Radiological Health (CDRH) is soliciting comment on a plan to create a network of outside scientific experts who would provide staff with rapid access to specific specialized knowledge about emerging technology, as well as other topics Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=539 Oct 11: EMA invites feedback on plans to revise existing guidelines on biosimilar medicines and influenza vaccines. Feedback for concept papers can be submitted until the end of December Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=538 PharmaTimes: While Europe spends considerably less per capita on biomedical research than the US, the investment is comparatively more productive in terms of the volume of journal publications that ensue, a new white paper released by the European Medical Research Councils (EMRC) has found Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=537 Forbes:With more drugmakers outsourcing more trials to CROs, few should be surprised that the CRO sector is generating investor interest. The attention-grabbing deal announced this week in which two private equity agreed to pay $3.9 billion in cash to buy Pharmaceutical Product Development is no random bet Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=536 UK’s NICE: Under new plans announced by the UK Department of Health, NICE is to take responsibility for providing advice on unlicensed and off-label medicines for use in special circumstances, helping patients with rare diseases get better access to drugs Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=535 Medical News Today: A report which outlines scientific activities that endorse product development as well as the medical device industry, while maintaining the efficiency and safety of products was released this week by the FDA’s Center for Devices and Radiological Health (CDRH Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=534 PharmaBiz: A discussion of “Clinical Research Malaysia” - a project established to promote and develop the growth of industry sponsored clinical trials in Malaysia, encouraging and supporting the pharmaceutical industry and CROs to select Malaysia as the preferred destination for contract clinical research and thus gain foreign direct investment from the global drug development industry Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=533 Cochrane Collaboration: Selective reporting of trial results occurs frequently, leading to exaggerated findings of the beneficial effects of healthcare interventions and underestimates of their harms resulting in patients unknowingly being treated with interventions that have little or no effect, and may cause harm. The Cochrane Collaboration has called for a number of measures to ensure all clinical trials data becomes publicly available, without undue delay. Related: Pharmalot 5Oct11: All clinical trial data must be disclosed Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=532 Mass Device: FDA device chief Dr. Jeffrey Shuren says the agency plans to release a raft of new guidances this year as it aims to stay on top of the 25 action items listed in its Plan of Action Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=531 R&D Magazine: Data from a clinical trial suggests that a new therapy may potentially serve as a "functional cure" for HIV/AIDS. The therapy, called SB-728-T, involves the modification of both copies of a patients CCR5 gene, which encodes the major co-receptor used by HIV to infect immune system cells Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=530 CentreWatch: U.S. venture capitalists are decreasing their investments in biopharmaceutical and medical device companies, reducing their concentration in prevalent disease areas and shifting investment away from the United States towards Europe and Asia, according to a report by the National Venture Capital Associations MedIC Coalition, which surveyed more than 150 venture capital firms Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=529 UK Government: This POSTnote summarises some of the most important reasons behind the decline in UK clinical trial activity, and the actions being taken to improve the situation. It also highlights areas identified by key industry partners as opportunities for growth Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=528 PharmTech Talk: The new Bribery Act 2010 the Act raises several concerns for Pharma that will need to be examined closely Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=527 Mass Device: Radio-frequency hypertension treatment, implanted aneurysm therapy and wearable robotic devices topped the list for Cleveland Clinics most innovative medical devices for 2012. The innovations spanned the range of health care from detection to treatment to data management Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=526 Newmarket Journal: A British couple with 5 surrogate children did not act with "reasonable care" when they conducted clinical trials on children, a court has heard. The couple are standing trial accused of fabricating test results for two clinical trials between July 2006 and June 2007. The UK’s MHRA, which is prosecuting the case, said it was the first case of its kind to go to court under the Medicines for Human Use (Clinical Trials) Regulations. Related: BBC News 5 Oct 11: Couple deny clinical trial charges Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=525 nbsp; 6 Oct 11Harvard Business Review: Why Good Leaders Pass the Credit and Take the Blame Its no big news that leaders in turnaround situations tend to play a more prominent role in their companies than leaders in business-as-usual scenarios. Whats interesting is, in interviews, the CEOs who had led turnarounds took personal responsibility when things went wrong and did not hesitate to share the credit with their teams when things went right. 6 Oct 11, Sci Am Guest Blog: Molecules to Medicine: Clinical Trials for Beginners [The first in a series of posts to outline the history and process for clinical trials]. 3 Oct 11, BMJ: Estimating treatment effects for individual patients based on the results of randomised clinical trials [Data from randomised trials can be used to predict treatment effect in terms of absolute risk reduction for individual patients, based on a newly developed model or, if available, existing risk scores.] 3 Oct 11, BMJ: Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8. [Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal] October Journal of Clinical Research Best Practices. Articles include The changing medical device regulatory environment, constructive site audits, and site managed recruitment. 29 Sep 11, Wired Science: Data-Mining Could Predict Heart Attack Risk [A team of researchers has used data-mining and machine-learning techniques to find subtle changes in electrical activity in the heart that can be used to predict potentially fatal heart attacks.] 28 Sep 11, Trials: Failure to report protocol violations in clinical trials: A threat to internal validity? [A study of 80 published trials found protocol violations to be under-reported and recommends the CONSORT statement be updated to provide explicit guidance on reporting protocol violations]. 23 Sep 11, PLOS One: Comparison of EDC with the Standard Data Capture Method for Clinical Trial Data [EDC solutions have the potential to produce similar data accuracy compared to paper-based methods. Given the considerable reduction in the time from data collection to database lock, EDC holds the promise to reduce research-associated costs. However, the successful implementation of EDC requires adjustment of work processes and reallocation of resources.] 22 Sep 11, BNet: 23 Sure-Fire Ways To Improve Your Presentations 27 Jun 11, BNet: Fighting Boredom and Anxiety at Work Balancing skill and challenge in order to manage boredom and anxiety at work – what to do and what not to do as managers Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=524 nbsp; 7 Oct 11: Required Advisory Statements for Medicines Label updates 5 & 6: Submissions & TGA response to submissions 7 Oct 11: Prescribing medicines in pregnancy database updated 4 Oct 11: Medicines Safety Update Vol 2, No 5, October 2011 released 30 Sep 11: Prescription medicine BPR update newsletter, September 2011 released Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=523 Australian Life Scientist: Health and medicine research funding is costly and somewhat random, with chance playing a large role in determining who receives research funding and who doesn’t Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=522 Medicines Australia: The recent shortage of injectable penicillin in Australia illustrates the importance of maintaining a viable Australian medicines industry. This post reflects on the need to have a debate about providing incentives to Australian manufacturing to ensure the supply of medicines is efficient and viable Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=521 DIISR Media Release: A better understanding of the human brain and diseases of the central nervous system is closer thanks to the new Centre for Neural Engineering at the University of Melbourne. Established through a $17.5 million research infrastructure grant from round 2 of the Australian Government’s Education Investment Fund (EIF), the centre will bring together scientists and researchers who are leaders in their fields Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=520 DoHA Ministerial Media Release: Copy of an article by Minister for Health and Ageing Nicola Roxon published in The Australian Financial Review around eHealth privacy legislation Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=519 PharmaPhorum: In this article, Mabel Tsui will consider the practice of off-label prescription by medical practitioners and hospitals in Australia, as well as some lessons from the US in terms of potential implications pharmaceutical companies may face during the course of promotion Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=518 ABC News: The Pharmacy Guild of Australia says its deal to promote Blackmore complementary medicines has been withdrawn because of "ill-informed and inflammatory" community outrage Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=517 Australian Life Scientist:Good things really do come in small packages, and they dont come much smaller than the nano-containers being developed by Frank Carusos team in Melbourne Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=516 ABC Science Australia and New Zealand have the highest incidence of the deadly skin cancer, melanoma, in the world. Now two studies at opposite sides of the globe have unearthed four genes that increase the risk of the disease Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=515 Croakey Dr Becky Freeman, a Lecturer in the School of Public Health at the University of Sydney, writes: The month of October not only brings the delights of warmer and longer evenings, but also heralds the arrival of an ocean of feel-good pink shopping and events Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=514 ABC Science: There is no need for most people to take vitamin supplements and some may even be linked to an increased risk of premature death in older women, according to a new study Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=513 Medical Observer: MERCK Serono has been fined $20,000 over a news item that was found to have been promoting the drug Movectro directly to the general public Wed, 12 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=512 nbsp; 28Sep11 Sci Transl Med: Disclosure of Clinical Trial Results When Product Development Is Abandoned [Commentary on value of disclosing results. Subscription required to access full article]. Related: UC Health, 28 Sep11: Commentary calls for drug companies to report all clinical trial results 27 Sep 11 PLOS Medicine: Why Drug Safety Should Not Take a Back Seat to Efficacy 27Sep11 PLOS Medicine: Cardiovascular Risk with Non-Steroidal Anti-Inflammatory Drugs: Systematic Review of Population-Based Controlled Observational Studies 23Sep11 Science: Rethinking Clinical Trials. [An editorial that discusses the need for regulatory reform to create a system that does more with fewer patients, given the industry move toward biologics and personalized medicine. Subscription required to access full article]. 21 Sep 11 Pharmacoepidemiol Drug Safety:Pharmacovigilance systems and databases in Korea, Japan, and Taiwan. [Abstract only. This article aims to qualitatively describe the characteristics of spontaneous reporting systems, signal detection methods, and observational databases in Korea, Japan, and Taiwan.] 21Sep11 PLOS Clinical Trials: Completeness and Changes in Registered Data and Reporting Bias of Randomized Controlled Trials in ICMJE Journals after Trial Registration Policy Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=511 nbsp; 30 Sep 11: Adverse drug reactions: Australian statistics on medicines 2010. The annual report from the Office of Product Review includes a brief overview on the various aspects of post-market monitoring of medicines in Australia. In 2010 the TGA received approximately 14,200 reports. 28 Sep 11: Consultations on adoption of European Union guidelines in Australia. 15 guidelines proposed for adoption including non-clinical and clinical development topics, electronic data, and drug safety. Comments due by 9 Nov. 26Sep11: 2012 meeting dates for the Advisory Committee on Non-prescription Medicines added Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=510 National Press Club: Dr Brendan Shaw, chief executive of Medicines Australia, will ask Where do your medicines come from and why should you care Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=509 The Pharma Letter: Medicines Australia has commenced a Review of its Code of Conduct and invites public submissions. The news came just a couple of days after the local subsidiary of UK drugs giant GlaxoSmithKline challenged rivals to follow the company’s action in revealing payments made to physicians and health-related organizations. Related: Medicines Australia Media Release Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=508 DoHA: Government has established an expert panel of prominent individuals with experience in and understanding of: health and medical research; health service delivery to the community; business; and philanthropy, to conduct an independent review of health and medical research in Australia. The Government anticipates receiving a final report from the panel in late 2012. Related: Ministerial Media Release Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=507 nbsp; 28Sep11: Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products. This guidance describes a two-step process on how to request that a new condition be added to the over-the-counter (OTC) drug monograph system. 26Sep11: Guidance for Industry User Fee Waivers, Reductions, and Refunds for Drug and Biological Products. This revised guidance describes (1) the types of waivers, refunds, and reductions available under the user fee provisions of the Act; (2) the procedures for requesting waivers, refunds, or reductions, and reconsiderations and appeals of FDA decisions on such requests and; (3) clarification on related issues such as user fee exemptions for orphan drugs. 22Sep11: Guidance for Industry- Reproductive and Developmental Toxicities — Integrating Study Results to Assess Concerns. This guidance describes an approach to estimating possible human developmental or reproductive risks associated with drug or biological product exposure when a nonclinical finding of toxicity has been identified, but definitive human data are unavailable. 19Sep11: Guidance for FDA Staff and Industry - Marketed Unapproved Drugs Compliance Policy Guide. This Compliance Policy Guide describes how we intend to exercise our enforcement discretion with regard to drugs marketed in the United States that do not have required FDA approval for marketing Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=506 nbsp; 30Sep11: European Medicines Agency launches new database of European experts. The database allows the public for the first time to directly search for the declarations of interests of all experts who have been nominated by competent authorities for medicines regulation across the European Union to be involved in the Agency’s activities. 28Sep11: Report on the implementation of the EMA/CHMP think-tank recommendations. Areas addressed and recommendations on new emerging issues Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=505 DoHA Ministerial Media Release: The rules governing the location of pharmacies in Australia will be fairer and more transparent following changes that come into force from 18 October Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=504 ABC Online: The details of the FDAs criticisms of CSL manufacturing operations have been obtained by News Limited newspapers under a Freedom of Information request, based on two years worth of audit reports. CSL says the items listed in the FDAs reports are observations only and do not represent the regulators final determination of compliance, which would only be made after CSL has a chance to respond to the observations Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=503 The Economic Times, India Nearly 1,600 people died during clinical drug trials conducted by various multinational pharmaceutical companies in India in the 2008-10 period but the compensation was paid only in 22 cases, according to the Directorate General of Health Services Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=502 SMH: Since being made made aware of an impending temporary shortage of Peniccilin on Monday, the TGA has found another source of penicillin from overseas, averting a possible shortage of the drug in Australia Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=501 Fast Company: The new tank top is less intrusive and more comfortable than traditional biomonitoring systems, say researchers. It also is cheaper, washable, has electrodes that measure and record bioelectrical activity, has a removable thermometer and accelerometer that measures temperature and movement, and finally a separate positioning device that allows doctors and nurses to keep track of where patients are Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=500 Croakey Blog: A discussion piece on current issues affecting PBS policy, from the Parliamentary Library’s blog FlagPost Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=499 PharmaTimes: Discussion Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=498 DoHA Ministerial Media Release: Minister for Health and Ageing Nicola Roxon today announced the Chair and members of the National Lead Clinicians Group. Dr Russell Stitz will be Chair. Other members include: Mr Tim Benson; Dr Mark Bowman; Professor David Clarke; Professor Nicholas Glasgow; Ms Helen Gosby; Ms Melissa Locke; Dr Alasdair MacDonald; Professor Tracey McDonald; Dr Jennifer May; Dr Ameeta Patel; Dr Andrew Pesce; Ms Toni Riley; Dr Mark Wenitong; Associate Professor Craig Whitehead Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=497 Boston Business Journal: PHT Corporation has launched a smartphone app that will allow pharmaceutical and biotechnology companies to manage clinical trial compliance data. Drug executives would have instant access to global clinical trial sites through the app. The app allows clinical trial site monitors to locate patients who need follow-up and one tap immediately calls the site to expedite any issues Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=496 The Australian: A complaint against former Australian of the Year Patrick McGorry for planning a trial of drugs on children has been dismissed. But the 13 international health experts who lodged the complaint with the ethics committee at Melbourne Health calling for the trial to be abandoned say they are dissatisfied with the finding and have lodged a complaint against the ethics committee Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=495 InPharm: Medical researchers are calling for regulatory red tape to be snipped away from the legal requirements around clinical trials in Europe. A joint statement to the European Commission and MEPs by 16 organisations - including Cancer Research UK, the Wellcome Trust and British Heart Foundation (BHF) - says the rules around trials need to be stripped back to avoid stifling medical advances. Related: PharmaTimes 27Sep11: Academia and industry push for revisions to Clinical Trials Directive Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=494 Mass Device: Karen Sandler, the woman in charge of open-source software company GNOME, has fought for the right to inspect the source code running her Medtronic EnTrust implanted defibrillator since she received the implant in Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=493 Fierce Pharma: Anytime a drugmaker launches a new product--especially a highly touted potential blockbuster--it risks disappointment. And investors are getting more cautious Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=492 DIISR Ministerial Media Release: The 2011 Strategic Roadmap for Australian Research Infrastructure sets out the Government’s priority areas for national, collaborative research infrastructure over the next five to ten years. This roadmap sets out the facilities that will be needed by researchers and industries around the world, to foster partnerships and lead to groundbreaking discoveries and practical solutions Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=490 DoHA Ministerial Media Release: The Minister for Health and Ageing, Nicola Roxon, has released the draft eHealth records legislation for public consultation.“The draft legislation outlines the process by which consumers, health care organisations and data repositories will register to be part of the eHealth system. It also will establish a new independent advisory council to advise the Government on the operation of the system.” Comments on the legislation will be open until Friday 28 October. Related: Aus Health IT Blog 3Oct11: Links to articles from a range of stakeholder sharing their viewpoints on this draft legislation Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=491 Mass Device: Eleven Notified Bodies have reportedly now signed the code of conduct ahead of a highly anticipated recast of the European Medical Devices Directive Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=488 The Australian: The federal government has decided to list a number of drugs on the PBS that it had previously deferred considering. The government relented on one drug in June and the remaining six are among 48 new medicines added to the list today. Related: Ministerial Media Release Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=489 Mass Device: One problem - how do you use devices like adopting iPhones, iPads, and iPod Touches in the wet and messy world of medicine? The answer - a waterproof "case" called a Frog Skin Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=487 Otago Daily Times: Community pharmacists and general practitioners are being encouraged to take part in a pilot programme designed to find out more about medication errors and how to prevent them. The Medication Error Reporting and Prevention pilot is funded by the Ministry of Health and is being run by the national pharmacovigilance centre at the University of Otago Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=486 The Australian: The battle lines are drawn over Bill Heffernan’s private members bill to ban gene patenting. On one side sit industry bodies such as Medicines Australia and the Institute of Patent and Trade Mark Attorneys, biotech and pharma industry groups and a handful of research institutes seeking funding through patents. On the other side sit clinicians and advocacy groups such as Cancer Voices Australia and Cancer Council Australia Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=485 Mercury News: A Silicon Valley pioneer-turned-medical activist, Grove, 75, is afflicted with Parkinsons disease. His worsening tremors fuel an impatience, offering daily reminders of the need to speed innovation into fatal neurodegenerative conditions. He has proposed a way to reform clinical trials so theyre faster and need fewer patients and he wants drug companies, like tech companies, to learn from their failures and build data-driven feedback loops Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=484 SMH: Pharmacists have started advertising their opposition to the Pharmacy Guild of Australias deal with Blackmores to start marketing its dietary supplements like coke and fries with prescription drugs. Doctors have also begun warning patients about the controversial scheme and directing pharmacists not to participate Thu, 06 Oct 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=483 nbsp; US AHRQ: Research review 23 Sep 11 - Nonpharmacologic Interventions for Treatment-Resistant Depression in Adults MJA 19Sep11: Adverse events associated with 2010 CSL and other inactivated influenza vaccines Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=482 nbsp; 23Sep11: Reforms to the medical devices regulatory framework: Proposals.As a result of the Health Technology Assessment review and consultation process, the TGA has refined and modified its recommended reform proposals. 23Sep11: Australian pharmacovigilance guideline for sponsors. Draft PV guidelines delayed and will not be coming into effect on 1 October 2011. Current guidelines summarised. 21Sep11: Updated contact details for the ARTG Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=481 nbsp; 22Sep11: Guidance for Industry on Reproductive and Developmental Toxicities--Integrating Study Results to Assess Concerns. This guidance describes an approach to estimating possible human developmental or reproductive risks associated with drug or biological product exposure when a nonclinical finding of toxicity has been identified, but definitive human data are unavailable. 20Sep11: Revised Guidance on Marketed Unapproved Drugs; Compliance Policy Guide Sec. 440.100; Marketed New Drugs Without Approved NDAs or ANDAs. CPG 440.100 describes how FDA intends to exercise its enforcement discretion with regard to drug products marketed in the United States that do not have required FDA approval for marketing. All unapproved new drugs introduced onto the market after the date te guidance is published are subject to immediate enforcement action at any time, without prior notice and without regard to the enforcement priorities set forth in CPG Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=480 Cordis: An EU-funded pan-European initiative to operate a sustainable infrastructure for managing and safeguarding biological information in Europe has been given the go-ahead by five European countries as well as the European Bioinformatics Institute (EBI), part of the European Molecular Biology Laboratory (EMBL) in the United Kingdom, the projects coordinating institution Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=479 NY Times:A new proposal tied to President Obama’s deficit reduction plan released this week would reduce the market exclusivity period for brand-name biologic drugs to seven years, from the 12-year period passed as part of last year’s US healthcare reform bill Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=478 InPharm Technologist: A new report in the MJA has suggest deoxycholate, used to disrupt influenza viruses during vaccine manufacture, may have been the cause of adverse events associated with CSLs paediatric influenza vaccine. [See also Articles of Interest- MJA article] Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=477 Ministerial Media Release: The Acting Minister for Health and Ageing, Mark Butler today officially launched the Centre of Research Excellence in Rural and Remote Primary Health Care. The new CRE will research and report on services in small, rural, remote and other communities and guide the Government in its ongoing primary health care reform Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=476 News.com.au: The chances of a body rejecting a transplanted organ could be dramatically reduced, thanks to a new discovery about how the liver works. Scientists at the Centenary Institute in Sydney have discovered that the liver destroys "killer" T-cells, which target donor organs and as a result stop the immune system from rejecting it Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=475 The Australian: More than 80% of Australians with sensitive medical information are concerned about the shift to electronic records. A Harris Interactive survey of 5246 people living in Australia and in the US and Britain found a remarkable correlation of results, with 83 % of Australians, 80 % of Americans and 81 % of Britons indicating a range of worries Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=474 Genetic Engineering & Biotech News: Before issuing its long-awaited draft guidance on biosimilars, FDA has offered some hints about how it will address biosimilar approvals in a NEJM paper. Despite those hints, questions remain about the issues FDA will cover in its guidance as well as how those rules will mesh with the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which authorizes the agency to develop a pathway that avoids unnecessary biosimilar tests Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=473 PharmTech Talk: Several things are changing in regulatory inspections in the US and industry should be prepared. Zena Kaufman, division vp of global pharmaceutical operations at Abbott, highlighted what’s new in domestic inspections at the PDA-FDA 2011 Joint Regulatory Conference taking place this week in Washington, DC Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=472 RAPS:This article examines several illustrative cases of ineffective risk management and offers a solution to achieving greater risk management program maturity and effectiveness Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=471 Media Release: Australian GPs believe that the governments deferral of listing new medicines on the PBS will hurt the quality of treatment that patients receive, according to research conducted by Kantar Health. In addition, half of the GPs said the changes would have a negative impact on how they practice medicine Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=470 Australian Life Scientist: Associate Professor Martina Stenzel is developing polymer nanoparticles that can help target the effects of chemotherapy drugs on tumours while sparing healthy cells Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=469 Research Australia Media Release: The Report of the Senate Legal and Constitutional Committee Inquiry into the Patent Amendment (Human Genes & Biological Materials) Bill 2010 was tabled in the senate last night, with a recommendation that the bill should not be passed. Related: Medicines Australia Media Release 23Sep11: No case to ban patents on genetic materials - Senate Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=468 Chemistry World: Ionic liquid drugs can rapidly pass through the skin and may open the way to new, more effective medicines, say scientists in Australia. They could also be a solution to some of the most significant problems in the pharmaceutical industry, they say Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=467 The Australian: In September 1961, French-born Australian scientist Jacques Miller published a paper that revolutionised the field of immunology. Five decades on, the Walter & Eliza Hall Institute immunologist is odds-on to receive the ultimate recognition of his work -- the Nobel Prize for Physiology or Medicine, to be announced in Stockholm on October Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=466 UCSF: To help disseminate information about pediatric clinical trials, the UCSF Division of General Pediatrics has launched a new website called CHIPPER – Children Helping Pediatric Practice, Education & Research – that offers a clearinghouse for streamlined access to the latest news and information on UCSF’s general pediatric clinical trials Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=465 FierceBiotech: Eli Lilly and Company have announced findings from a prospectively designed observational study that resulted in new ways to increase minority participation in clinical trials Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=464 Mass Device: The health care industry is ill prepared to protect patients medical records as new uses for data arise, according to a report by PricewaterhouseCoopers LLC Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=463 Media Release: A new study by Cutting Edge Information found that drug companies spend an average $5,856 per patient to fund a Phase IV clinical trial in the United States. Companies costs per patient ranged from $1,000 at the low end to more than $12,000 at the high end. Typically, the more expensive per-patient costs are for Phase IV trials that study oncology or urology Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=462 Irish Times: What he is proposing, and has agreed with a number of governments, is a new, more flexible pricing approach, reflecting that drugs may deliver a range of results in different patients. Flexible pricing is an effort to persuade cash-strapped healthcare businesses, largely governments, not to simply block drugs on grounds of cost or to continually cut prices Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=461 Courier Mail: Health authorities have failed to keep up with an explosion in natural therapists as lives are put at risk from untested, unproven and potentially dangerous services. More than 200,000 practitioners work in unregistered health fields Australia-wide and complementary medicines generate almost $2 billion a year, but little can be done when treatments go wrong Wed, 28 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=460 The Clinical Trials Action Group (CTAG) was established in October 2009 to identify and progress necessary reforms to secure Australia’s competitiveness in the clinical trials sector. Its report, Clinically competitive: boosting the business of clinical trials in Australia, was released in March 2011. Industry groups such as Medicines Australia and ARCS members have contributed to this report and its ongoing implementation. Following the release of the report, Consumers Health Forum was funded by the Department of Innovation, Industry, Science and Research to develop a factsheet to provide consumer-friendly information about clinical trials, in response to a recommendation for improved consumer access to information on clinical trials. CHF members were engaged in focus testing and many provided input into the content and development of the factsheet. CHF CEO, Carol Bennett formally launched the factsheet at the Joint Medicines Policy Conference on 30 August 2011 in Canberra. The factsheet is available online, in both colour and print-friendly versions Tue, 27 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=459 nbsp; 16 Sep 11 ARHQ: Development of the RTI Item Bank on Risk of Bias and Precision of Observational Studies 13 Sep 11 PLOS Medicine: Strengthening the Informed Consent Process in International Health Research through Community Engagement: The KEMRI-Wellcome Trust Research Programme Experience Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=458 nbsp; 16 Sep 11: Draft Guidance for Industry - Self-Selection Studies for Nonprescription Drug Products:This guidance is intended to provide recommendations to industry involved in developing and 21 conducting self-selection studies to support an application for nonprescription drug products Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=457 nbsp; 14 Sep 11: EU Clinical Trials Register recognised as primary registry of WHOs International Clinical Trials Registry Platform. EU-CTRs recognition means that its information will be available through this portal by the end of the year, once the technical processes to allow transfer of the information are complete Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=456 The Economist: Investigations into a case of alleged scientific misconduct have revealed numerous holes in the oversight of science and scientific publishing Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=455 John Hopkins Nursing: Authors of a new study have found that African American and white women are significantly different in their responses to various forms of mass media and personal techniques aimed at recruiting them for a clinical study Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=454 FT.com: US medical researchers injected more than 1,300 Guatemalans with sexually transmitted diseases after the second world war in clinical trials that represented “gross violations of ethics”, a US government inquiry found Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=453 Media Release: The Scleroderma Research Foundation announces the first in a series of free informational Webinars for people living with scleroderma and others directly or indirectly affected by the disease which will highlight new clinical trials and results from recent studies Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=452 Pharmalot: A TUFTs study has found nearly 60 percent of all protocols used in clinical trials for new drugs are amended during the trial, but one-third of those changes could have been avoided and saved countless dollars. Related: TUFTS Media Release Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=451 Mass Device: The U.S. is on the verge of the largest shift the patent system has seen in decades as President Barack Obama prepares to sign a bill that will transform the process from a first-to-invent system to a first-to-file system Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=450 CentreWatch: General Electric joined four venture capital firms in pledging $100 million for a six-month contest to finance ideas for improving breast cancer detection, according to Bloomberg Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=449 Outsourcing Pharma: Pharma industry sponsors want more effective ways of measuring CRO performance according to the team behind a new project aiming to develop a validated set of analysis tools Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=448 PharmaTimes: With momentum building for open-access publishing and debate continuing to rage about access to clinical trial data, the UK government is setting up an independent working group to look at how UK-funded research findings can be made more widely available Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=447 PharmaTimes: Research reported in the Archives of Internal Medicine September issue found that 39% of participating adults believed that the FDA only approves prescription drugs that are "extremely effective," while 25% thought the agency only approves products which do not have serious side effects Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=446 Mass Device: Apple dedicates a portion of its AppStore to help docs find the best health care apps for the iPad and iPhone. Called "Apps for Healthcare Professionals," it currently includes 49 apps for iPhone users and 52 for iPad Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=445 The Guardian (UK): Great Ormond Street childrens hospital trust said it has for the first time transferred the medical history of one of its patients to St Marks hospital, Harrow, using online tool Patients Know Best, a patient controlled healthcare records system Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=444 Information Week: Natural language processing programs can now data mine e-records to help locate the best candidates for clinical trials. Several major healthcare organizations have taken notice Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=443 Boston Herald: An author who studied 20 so-called human guinea pigs says “lies and deception” by medical-test volunteers desperate for money may have negative effects on the results of clinical trials of new drugs and techniques Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=442 nbsp; 15Sep11: The TGA provides consumers with advice on buying appropriate medical devices 12 Sep 11: The recent presentations about the regulation of biologicals have now been uploaded to the TGA website Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=441 Croakey Blog Consumers have been campaigning for better regulation and monitoring of complementary medicines for some time Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=440 QLD Business Review: University of Queensland biotech start-up, Spinifex Pharmaceuticals, has secured $6.3 million in funding to continue clinical trials of its innovative nerve pain therapy. This latest boost is the final tranche of an $18.3 million investment, and follows the success of its phase one clinical safety trials Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=439 AusMedIndustry Blog: Dr Brendon Saw reflects on how little the community appreciates the contribution of the pharmaceutical industry to clinical trials in Australia Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=438 The Australian: The Medical Software Industry Association has warned that the Gillard governments $500 million e-health records rollout is a "standards-free zone" that will lead to massive costs and risks sinking local e-health providers Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=437 HealthCanal.com: Australians are paying more out of their own pockets for medicines than people in many other countries, according to a new study. Related: The Australian 14Sep11: Scripts not filled as medicine prices soar Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=436 Medicines Australia: The Federal Government can build consumer and industry confidence in its management of the healthcare reform agenda by addressing its missteps with the PBS, Medicines Australia chief executive Dr Brendan Shaw told industry experts at the annual eyeforpharma Sales and Marketing Excellence Conference Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=435 Fierce Biotech: Abbott has been named one of the top 20 employers in Science magazines 2011 Top Biopharma Employers survey. According to the survey, Abbotts top three characteristics are: conducting important, quality research; being socially responsible; and treating employees with respect Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=434 DoHA Media Release: An article written by Minister for Health and Ageing Nicola Roxon and published on 6 Minutes outlining the benefits the public can expect to see from the eHealth project. Related: 18Sep11 AusHealthIT Blog: Blogger discusses the above article and other recent commentary on PCEHR Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=433 NZACRes: A new, standardised Clinical Trial Research Agreement has been released by the NZ Association for Clinical Research (NZACRes) for use by sponsors and clinical trials sites. It is based on the Medicines Australia template Thu, 22 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=432 nbsp; Sept 11 Drug Safety via PubMed: The case-population study design: an analysis of its application in pharmacovigilance. Although the case-population approach suffers from limitations stemming from its main advantage, i.e. impossibility to control possible confounders and to quantify the strength of associations due to the absence of an ad hoc control group, it is particularly useful to use in routine practice, mainly for purposes of signal generation and hypothesis testing in drug surveillance. Sep 11 JCRBP: Monitoring with an Auditor’s Eye. Article provides a few strategies monitors can adopt to use an “auditor’s eye” in their work. Sep 11 JCRBP: Making Sense of Biostatistics: Relative Risk, Absolute Risk Difference, and Odds Ratio explained. 9 Sep 11 Trials Journal: When is informed consent required in cluster randomized trials in health research? This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. 6 Sep 11 PLOS Medicine: Towards Improved Measurement of Financial Protection in Health. A broader set of metrics is required to better inform policy development on financial protection, including new indicators that identify citizens who cannot afford to use health services and may have very low or no health spending. Forbes: 6 Sep 11 Serial LifesaverPeter Hirth is showing the pharmaceutical industry a nimbler way to come up with breakthrough medicines. His strategy: launch small startups that can deliver big drugs to big pharma Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=431 Sep 11: Concept paper on implementing measures for the performance of pharmacovigilance activities released for consultation. Comments due by 7 Nov Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=430 The Scientist: The scope of global pharmacovigilance programs is not on par with the distribution of the drugs intended to be monitored. Sustainable global pharmacovigilance requires re-thinking how reports of patient events around the world can be generated, coded, and analyzed but the future of safe and effective medicines requires it Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=429 InPharm: The European system of comparing drugs against placebo and not against a comparator is flawed, according to a new London School of Economics report. It argues pharma companies should show how their drugs compare to existing treatments before approval, so that only the most beneficial and safest therapies reach patients Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=428 Media Release: A new report by visongain predicts that global pharmacovigilance spending will be worth $15.46bn by 2015, up from just under $12bn in Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=427 Boston Globe:Testing of several potential Alzheimer’s medications has yielded recent disappointments, but important lessons can be gleaned from those failures, including completing basic laboratory tests before moving on to clinical trials Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=426 Family Practice News: A consortium looking at data from randomised controlled trials of antipsychotics in patients with schizophrenia have made 3 recommendations: 1. efforts should be made to dramatically increase the number of women in studies; 2. placebo-controlled efficacy trials in this indication could be shortened by 1 to 2 weeks and; 3. sensitivity analysis should be included Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=425 PharmaTimes: New Zealands government has begun rolling-out a new national drug formulary - New Zealand Medicines Formulary (NZMF) - which it says will be a "true one-stop-shop covering clinical information as well as classification and subsidy status" on medicines Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=424 PharmaTimes: The pharmaceutical industry is now entering a new era in which it can, for the first time, prove that its products work, but realising the full benefits of this will require a "seamless relationship" between the industry and the NHS, says Stephen Whitehead, the Association of the British Pharmaceutical Industry (ABPI)s new chief executive Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=423 NY Times: Two advisory panels to the FDA on Friday recommended increasing the cautionary language on the product labels of bone-building drugs taken by more than five million women in the United States. But they stopped short of specifying what the safety warnings should say and did not recommend limiting use of the drugs to a proposed five years Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=422 Mass Device: Thousands of patient medical records from Stanford Hospital containing names and diagnosis codes were publicly exposed on a commercial website for nearly a year before being caught last month Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=421 Science Insider: A newspaper revealed that Servier has come under fire from the EMA for the way it studied the side effects of its drugs after they reached the market. Separately, leaked court testimony have suggested that Servier deleted unfavorable information from the files with which it sought regulatory approval for Mediator, its diabetes drug, in the 1970s Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=420 The Herald-Sun: Two cancer patients and the estates of six others have sued Duke University and the Duke University Health System, accusing them of negligence and other wrongs stemming from disgraced researcher Anil Potti’s work Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=419 The Age – "Successive state governments have promoted and supported a plethora of disconnected, poorly capitalised and poorly funded research institutes, largely driven by ego and political opportunism. This has resulted in an entirely fragmented and dysfunctional research infrastructure in this state, and has meant that NSW languishes below the other main states Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=418 CHF: In partnership with the Department of Innovation, Industry, Science and Research, CHF has developed a consumer factsheet on the clinical trials process and consumer participation in trials Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=417 NHMRC: Singapore’s Agency for Science, Technology and Research (A*STAR) and Australia’s National Health and Medical Research Council (NHMRC) have signed a Memorandum of Understanding (MOU) to promote exchange between the two countries in the areas of health and medical research Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=416 The Age: The TGA is considering the radical option of requiring alternative medicines to contain an untested disclaimer on their labels, much to the disdain of the alternative medicines industry Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=415 Minister for Mental Health and Ageing Media Release: Australians living with mental illness are a step closer to being able to access online care and support following the establishment of a new e-mental health expert committee which will advise on the rollout of the nation’s first mental health online portal and virtual clinic Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=414 Minister for Health and Ageing Media Release: The plan charting the path for national health reform implementation was released today by Minister for Health and Ageing Nicola Roxon. It outlines the plans and milestones to be met in achieving health reform in: hospitals, GP and primary care, aged care, mental health, national standards and performance, workforce, prevention and eHealth Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=413 The Age: Women more than double the risk of miscarriage by taking anti-inflammatory drugs such as Nurofen and Voltaren in early pregnancy, research shows. The TGA is to review the study to assess whether to strengthen warnings about the possible effects of taking such drugs during pregnancy Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=412 Australian Life Scientist: Eureka Award winners this year include a team saving the Tasmanian devil, the developers of the Nanopatch needle-free vaccine delivery system, a WEHI team working on a malaria vaccine, professors who showed high blood pressure is linked to over-stimulation of the kidneys by a sympathetic nervous system, and Associate Professor Kevin Pfleger, who has sought to improve treatments for conditions as disparate as drug addiction, prostate disorders and kidney failure Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=411 Radio NZ: The NZ Government says its going to streamline and simplify the application process for those wanting to conduct clinical trials of medicines, medical devices or therapies in this country. The decision announced on Tuesday follows a critical report on the clinical trials environment from Parliaments health select committee. Related: NZ Govt Press release 7 Sep Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=410 The Australian: Damien Finniss (Royal North Shore Hospital) and collaborators in Europe, the US and elsewhere seek to understand how the different aspects of the psychosocial context in which treatments are given combine to activate patients "internal placebo mechanisms" with a view to find ways of maximising its benefit for patients Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=409 The Australian: Damien Finniss (Royal North Shore Hospital) and collaborators in Europe, the US and elsewhere seek to understand how the different aspects of the psychosocial context in which treatments are given combine to activate patients "internal placebo mechanisms" with a view to find ways of maximising its benefit for patients Tue, 13 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=408 DIISR Media Release: Information sessions, held across Australia in September and October, will help businesses learn how to access and best use the new R&D Tax Incentive to drive the development of new ideas, products and processes Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=407 DoH Media Release: Dr Tony Sherbon has been appointed the acting Chief Executive Officer of the interim Independent Hospital Pricing Authority (IHPA), beginning 1 September Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=406 Barnold Law: The Australian National Audit Office (ANAO) released on 30Aug11 a 198 page report on Therapeutic Goods Regulation: Complementary Medicines (ANAO Audit Report No.3 2011–121). In essence the report slams regulation by the Therapeutic Goods Administration (TGA). Related:ABC Online 31Aug11: Alternative treatments flouting medicine laws; The Age 31Aug11: Watchdog lacking on alternative medicine Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=405 Croakey Blog: Australia leads the world in many areas of public health but the Federal Government could be negotiating our achievements away, according to Dr Patricia Ranald, Convenor, Australian Fair Trade and Investment Network Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=404 Medicines Australia: A predictable regulatory and reimbursement environment, and a long-term policy outlook are essential if patients are to continue to have access to new medicines, Medicines Australia chief executive Brendan Shaw said at a Third Joint Medicines Policy Conference in Canberra yesterday Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=403 The Australian: The National E-Health Transition Authority has collared an estimated $200 million so far for the 18-month run-up to the Gillard governments personal e-health records launch next July 1, with more money to come Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=402 Australian Life Scientist: The appearance of a new mutant of bird flu in Asia raises the concern that it might hybridise with swine flu creating a new pandemic threat Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=401 CHF: The Hon. Catherine King MP, Parliamentary Secretary for Health and Ageing, this week addressed the CHF on health reform, TGA and ANZTPA activities, and reviews ongoing at the TGA. – A copy of her speech Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=400 NSW Health: An issues paper, compiled from the face-to-face meetings and online submissions received for the initial review questions last month and facts based have been released. Comments are invited on this paper by 26Sep11, using the submission guidelines provided Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=399 Medicare: From 1 December 2011, a new initiative will be introduced with the aim to reduce PBS expenditure on chemotherapy medicines that are used in treatment of cancer and administered through intravenous infusion or injection. This will result in changes to the PBS and new remuneration arrangements Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=398 Sep 11: The TGAs risk management approach: The purpose of this document is to describe the broad risk management approach adopted by the TGA Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=397 Milwaukee Sentinel Journal: Researchers are turning to computer models, meshing math and biology to develop a better understanding of the effectiveness of diagnostic tests and treatments Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=396 MedPage Today: The FDA has issued draft guidance that calls for drug and device companies to move away from in-person monitoring of each site in a clinical trial, when appropriate, and rely more on electronic data monitoring.(Free registration to read this page) Related:Pharmalot, 1 Sep 11: FDA urges remote monitoring FDA Guidance for Industry Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=395 MassDevice: Improper use of glucose monitoring and insulin delivery devices in clinical settings has the Centers for Disease Control & Prevention worried about an uptick in infectious disease transmission Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=394 HIT Buzz:The New England Journal of Medicine has released research showing that physician practices that use electronic health records had significantly higher achievement and improvement in meeting standards of care and outcomes in diabetes than practices using paper records Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=393 Reuters: A pioneering clinical trial to inject stem cells into the brains of patients disabled by stroke has been cleared to progress to the next stage after the treatment raised no safety concerns in the first three candidates Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=392 PharmaTimes: Clinical development should emerge as the fastest-growing segment of a global biomarkers market expected to reach US$34 billion by 2017, a new report from market researcher Global Industry Analysts predicts Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=391 India’s Business Standard: The National Human Rights Commission (NHRC) has sought a detailed report from apex health research body Indian Council of Medical Research (ICMR) and top drug regulator Drugs Controller General of India (DCGI) on clinical trials being conducted in India Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=390 Cadenagramonte.cu: Nearly 100 people died in Guatemala from 1946 to 1948 as a result of clinical trials carried out by U.S. scientists on 5,000 patients, a state commission confirmed on Tuesday. The clinical trials were carried out to prove the effectiveness of penicillin Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=389 Med Devices Daily: Chris Wasden, managing director, in the Strategy & Innovation practice at PricewaterhouseCoopers (New York), share his views on future directions in healthcare Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=388 Aug11: PET Drug Applications — Content and Format for NDAs and ANDAs 29Aug11: Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=387 Sep 11: European Medicines Agency provides update on electronic submission of information on medicines Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=386 Mayo Clinic Proceedings Sep 11: Electronic Communication and Medical Research: Beyond the Record PLOS Medicine 30Aug11: Ghostwriting Revisited: New Perspectives but Few Solutions in Sight PLOS Medicine 30Aug11: Building the Field of Health Policy and Systems Research: An Agenda for Action ABC 1 Sep Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=385 The Australian - Pharma giant CSL has blamed a world-first blending of flu virus strains as the likely cause of fits in children immunised with its flu vaccine last year Mon, 12 Sep 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=360 LifeScientist: The much-debated and long-delayed R&D Tax Credit has been given the go-ahead by the Senate, although it still needs to go through the House of Representatives for any amendments. Related: Life scientist: R&D Tax Credit will boost small biotechs The Australian Wayne Swan wins Senate vote for tax credit scheme Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=359 nbsp; 19 Aug 11 NY Times:Clinical Trials Neglect the Elderly.The Elderly are not well presented in clinical trials, a fact that undermines their doctors’ best efforts at providing treatment. This article discusses some of the reasons why this might be so. 17 Aug 11. Telegraph SMOKING increases the risk of bladder cancer significantly more than it did decades ago, new research suggests. 17 Aug 11 BBC Ovarian cancer clue raises blood test hopes 16 Aug 11, PLOS Medicine: Building the Field of Health Policy and Systems Research: Framing the Questions.This is the first of a series of three papers addressing the current challenges and opportunities for the development of Health Policy and Systems Research Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=358 Final Guidance for Industry - E2F Development Safety Update Report. 22Aug11The development safety update report (DSUR) proposed is intended to be a common standard for periodic reporting on drugs under development among the ICH regions. Draft Guidance for Industry - Standards for Clinical Trial Imaging Endpoints.18Aug11: The purpose of this guidance is to assist sponsors in the use of endpoints that depend on the results of imaging tests in clinical trials of therapeutic drugs and biological products. “Communicating Risks and Benefits: An Evidence-Based Users Guide”.18Aug11: This guide provides the scientific foundations for effective communication. Final Guidance for Industry - Residual Drug in Transdermal and Related Drug Delivery Systems. 16Aug11: This guidance provides recommendations to developers and manufacturers of transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products. Draft Guidance for Industry and FDA Staff - Postmarket Surveillance Under Section 522. 16Aug11: Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act is one means by which the FDA can obtain additional safety and/or effectiveness data for a device after it has been cleared through the premarket notification (510(k)) process or approved through the premarket approval application (PMA), humanitarian device exemption (HDE), or product development plan (PDP) process, when it is necessary to protect the public health. This guidance document is intended to assist those subject to section 522 postmarket surveillance imposed by FDA. Draft Guidance for Industry and FDA Staff - Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review. 16Aug11: FDA has developed this draft guidance document to provide greater clarity for FDA reviewers and industry regarding the factors FDA considers when making benefit-risk determinations during the premarket review process for certain medical devices Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=357 Amednews.com: Sweeping changes announced by the US Dept. of Health and Human Services would speed up the process of approving and monitoring federally funded clinical trials. This includes centralising IRB review, shortening consent forms, expediting review of low-risk research, electronic reporting of clinical-trial adverse events and broadening who is covered by the human research regulations. The deadline for public comment on the HHS advanced notice of proposed rule-making is Sept Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=356 Eurekalert Media Release: A study published online in the Journal of the American College of Cardiology has found after comparing several international clinical trials of beta-blocker drugs that there are notable differences in how well the drugs prevent deaths in heart failure patients, based on where the patients were treated. In this study, U.S. patients apparently had a lower survival rate with beta-blocker treatment compared to patients outside the U.S Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=355 Fierce Biotech: Deloitte, the accounting and consulting giant, is getting into the drug safety game, Intrasphere Technologies, which provides drug safety and regulatory services to its life sciences consulting group. A key asset in the buyout is Intraspheres PharmaCM - a content-management software that helps developers register clinical trial data on government-mandated registries - which Deloitte plans to make part of its managed analytics business Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=354 San Francisco Business Times: Roche Molecular Diagnostics (RMD) is positioned to be a major player in the personalized medicine revolution and is central to Roche’s mandate that the development plan for every therapeutic include a companion diagnostic or biomarker strategy. Paul Brown, CEO of RMD, talks about the company’s efforts, the FDA and the role of diagnostics in improving health care Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=353 Australian Life Scientist: US scientists have devised a drug-disease matchmaking program that mines databases for potentially useful new treatment combinations and has turned up two so far, says a study. Related: Wall Street Journal 18 Aug 2011 In a bit of high-tech recycling, researchers have developed an innovative way to identify already-approved drugs that may work against diseases they werent designed to combat Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=352 FierceBiotech: With Chinas government planning to pump hundreds of billions into its biotech sector, the country is motivating scientists from the U.S. and within its own borders to start biotechs Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=351 PharmaTimes: The FDA has a released a new Strategic Plan for Regulatory Science which outlines a sweeping modernisation of the science used in developing and evaluating the products over which it has oversight Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=350 Biologicals regulatory framework information sessions. The TGA will be conducting a number of information sessions around Australia over the next couple of weeks on the new biologicals framework Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=349 ABC News: Scientists have found a genetic mutation that makes some people more susceptible to colorectal, bowel and other cancers Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=348 The Australian: Public health physician Ken Harvey has been hit with a million-dollar defamation law suit by the director of a complimentary health care company under investigation by the consumer watchdog Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=347 Nine News: CSL has sent a detailed response to the FDA and met with its representatives in an attempt to address the concerns raised by the FDA in June about deviations from good manufacture practice standards and a failure to thoroughly investigate why the vaccine, sold as Fluvax in Australia and Alfuria in the US, caused reactions in some young children. Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=346 Govt Media Release: Prime Minister Julia Gillard and Minister for Health and Ageing Nicola Roxon have announced the appointment of the inaugural chairs of health reform bodies to drive transparency, accountability and efficiency Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=345 The Age; Medical Experts concerned about untested “natural” HRT being prescribed for woman with menopause. Related: Pharmacy News: 19 Aug 2011 Experts attack TGA over lack of controls on compounding pharmacists. (Full article only available to subscribers Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=344 The Australian: The government is preparing to back down on its controversial decision to delay subsidies for six new medicines and give cabinet a veto over every new drug subsidy after a revolt by consumers, doctors and drug companies. Related: Research Australia Media Release. 19 Aug 1;1Medicines Delay hinders Medical Research and Innovation Medicines Australia Media Release, 17 Aug 11: Senate report slams Cabinet PBS deferrals; GMiA Media Release, 18 Aug 11: GMiA welcomes Senate Finance and Administration References Committee report on Government administration of the PBS Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=343 The Australian: Scepticism about the security of the federal governments proposed system of electronic health records is running so high experts warn it threatens to render the $500 million system a white elephant. Related: Accenture to Build Australia’s Personal e-Health System 15 Aug 11 Dept of Health Media Release: Accenture, a world leader in IT, has been selected to lead the building of the IT infrastructure for Australia’s national personally controlled electronic health record (PCEHR) system in another major milestone for national health reform. Now Here Is An Article To Give Serious Pause To The Approach Being Adopted With the PCEHR 21 Aug 2011Australian Health Information Technology Blog Huge IT cost blow-outs Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=342 The Age: Former Australian of the Year Patrick McGorry has aborted a controversial trial of antipsychotic drugs on children as young as 15 who are "at risk" of psychosis, amid complaints the study was unethical. Related: Speed up Sit still 4 May 2011: Is Patrick McGorry’s blueprint for Australian mental health a prescription for more ‘psychiatric disorders’, ‘off label’ prescribing and youth suicide or the way forward Wed, 24 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=341 Aug 11, Ben Goldacre: Researchers dont mean to exaggerate, but lots of things can distort findings. Its possible people are not bothering to report a negative result alongside positive ones they found 9 Aug 11, PLOS Med: Being the Ghost in the Machine: A Medical Ghostwriters Personal View 9 Aug 11, PLOS Med: How Industry Uses the ICMJE Guidelines to Manipulate Authorship—And How They Should Be Revised 8 Aug 11, Arch Int Med: Improving Clinical Practice Guidelines—The Answer Is More Clinical Research (Full article only available to subscribers) 1 Aug 11, PLOS One: The Evidence Base for Interventions Delivered to Children in Primary Care: An Overview of Cochrane Systematic Reviews Tue, 16 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=340 Patent Docs: Discussion of an article published in the New England Journal of Medicine on August 4, in which US FDA executives presented a sneak preview of what to expect when the FDA issues its biosimilar standards under the Biologics Price Competition and Innovation Act (BPCIA) later this year Tue, 16 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=339 European Commission: The Innovative Medicines Initiative (IMI) is Europes largest public-private initiative aiming to speed up the development of better and safer medicines for patients. IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe. The 4th call for proposals has been announced, with submissions to be accepted from 19Sep-18Oct Tue, 16 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=338 Wall Street Journal: Since 2001, while the number of papers published in research journals has risen 44%, the number retracted has leapt more than 15-fold, data compiled for The Wall Street Journal by Thomson Reuters reveal. Just 22 retraction notices appeared in 2001, but 139 in 2006 and 339 last year Tue, 16 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=337 Mass Device: With the explosion of medical devices to treat various medical ailments in medicine, we have seen significant improvements in quality and quantity of life. An underappreciated consequence of all of these electronic device therapies, however, has been the manpower and expertise required to manage these implanted electronic medical devices long-term Tue, 16 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=336 Design Considerations for Pivotal Clinical Investigations for Medical Devices: This document is intended to provide guidance to those involved in designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. It describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfil premarket clinical data requirements. Comments due within 90 days. Related: ICH-E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions: The guidance describes recommendations regarding context, structure and format of regulatory submissions for qualification of genomic biomarkers (as defined in ICH E Tue, 16 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=335 Aug 11: Advisory Committee on Complementary Medicines (ACCM) Updated 2011 meeting dates & added 2012 meeting dates 12 Aug 11: TGA advisory committee guidelines - provide guidance for members on Declarations of interests, managing conflicts of interests and confidentiality obligations. 8 Aug 11: Reporting medical device problems. New online reporting forms for medical device adverse Tue, 16 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=334 Pharmabiz: Cancer Trials Australia (CTA) has entered into a collaborative agreement with Mumbai based Clininvent Research Private Limited (CRPL) with the aim to leverage complimentary capabilities in selected areas of clinical development and offer services spanning phases I to IV, to clients in Australia and India Tue, 16 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=333 DIISR Media Release: Encouraging Australians of all ages to get involved in National Science Week (13 to 21 August 2011), Innovation Minister Senator Kim Carr said the Gillard Labor Government was proud to be investing a record $9.4 billion in science, research and innovation because it wanted Australians to live richer, fairer and greener lives Tue, 16 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=332 Australian Life Scientist: A multi-national study that collected genetic samples from 9,772 individuals with MS and 17,376 individuals without, found that 20 variations of the genome previously associated with MS were confirmed, and uncovered 29 new variations that appear to increase susceptibility to the disease. Many of these variations occur around the major histocompatibility complex (MHC), some influence T cell differentiation and maturation, and links with vitamin D deficiency were found. Related: ABC News: MS genes found Tue, 16 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=331 Medicines Australia: Medicines Australia’s position on the Nov 2010 Private Members’ Bill containing a proposal to ban patents on “biological materials including components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature” Tue, 16 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=330 Medicines Australia: Medicines Australia’s Data Exclusivity Taskforce have finalised a position paper on why the term of data exclusivity in Australia should be extended from 5 years to 10 years and the value it would bring to Australia Tue, 16 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=329 ABC News: A team of German scientists have analysed more than 3,000 different blood samples and found men and women have considerable differences in 101 of the 131 metabolites present in human blood. Scientists say the physical difference between the sexes is so great that doctors should consider using different medical treatments on men and women Tue, 16 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=327 American, European and Australian Drug Regulatory Agencies increasing collaboration: Two reports were released today by the FDA (USA), EMEA (Europe) and TGA (Australia) reporting on two pilot programs aimed at widening international regulatory collaboration so that medication quality and safety can be secured worldwide Thu, 04 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=326 NSW Govt: The NSW Health and Medical Research Strategic Review committee has started work on a comprehensive 10-year plan to ensure NSW remains a world-leader in medical research and technology for decades to come. A series of roundtables and interviews will be held with key stakeholders over the coming weeks and public submissions to the review will open shortly. See Article for link to making submissions. Thu, 04 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=325 EMA: The European Medicines Agency is inviting expressions of interest from people with a scientific background or paediatric experience of ethics committees, paediatric research networks, the pharmaceutical industry or CROs for its workshop on the ethical considerations for paediatric trials, taking place at the Agency on 29-30 November Thu, 04 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=324 Pharmalot: Clinical trial costs are rising as a result of increased competition for trial sites and CROs that can yield reliable, high quality data, according to a recent Cutting Edge Information survey Thu, 04 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=323 PharmaTimes: Pharma companies are increasingly looking to contract research organisations but a number of risks may be overlooked, says KPMG. With the Bribery Act coming into play and a light being shone on compliance, building the right relationship with CROs is becoming very important. Pharma companies need to know what they are paying their CROs and what the CRO is paying third parties on their behalf Thu, 04 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=322 Medicines Australia: New publicly available Government data from Medicare Australia shows that Government expenditure on the Pharmaceutical Benefits Scheme grew by just over 5 per cent in 2010-11 – or less than 2 per cent in real terms. Medicines Australia chief executive Dr Brendan Shaw said today the new data, coupled with today’s release of the annual inflation figures, show that PBS spending is well under control Thu, 04 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=321 MedCityNews: North Carolina clinical research organization Cetero Research allegedly falsified clinical trial documents and test results over a five-year period, and now an undetermined number of drug companies who worked with the CRO must review their records to determine whether new tests on their drugs are required. Related: 28 Jul 11 Fierce Biotech: Cetero fires back at scathing FDA accusations Thu, 04 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=320 PharmaTimes: E-Patients are a huge untapped population of potential clinical trial participants, with more than 80% of patients online wanting to take part, a new survey by Blue Chip Patient Recruitment has found. According to the white paper, 81% of online patients were interested in participating in clinical trials but only 16% had done so, possibly due to a “serious lack of awareness about participation opportunities” Thu, 04 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=319 The Australian: More than 90 per cent of voters in marginal seats think doctors, not the federal government, should decide which medicines are available to patients, as the government battles a revolt from consumers and medicos over delays in drug subsidies Thu, 04 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=318 Forbes:As iPads spread virally throughout the healthcare industry, IT chiefs are left wondering if these new devices will compromise the security of their organizations. We are entering a world with more lightweight endpoint devices and more heterogeneous operating systems, and since these devices are often owned by the employee the IT team does not have control over the software running on these devices Thu, 04 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=317 The Sunday Telegraph: Professor Ian Frazer says he is on the verge of a major breakthrough in skin cancer and hopes to develop a vaccine within a year that will eradicate the disease from future generations Thu, 04 Aug 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=316 nbsp; 21 Jul 11 BMC Medicine: Can user testing of a clinical trial patient information sheet make it fit-for-purpose? - a randomised controlled trial. 20 Jul 11 Eur J Clin Pharmacol: A plea for a more epidemiological and patient-oriented pharmacovigilance. 12 Jul 11 PLOS One: Communication about Childrens Clinical Trials as Observed and Experienced: Qualitative Study of Parents and Practitioners Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=315 Jul11: Questions & answers about the streamlined submission process. 21Jul11: Prescription medicine BPR update newsletter, July 2011 18Jul11: Pioglitazone and risk of bladder cancer safety advisory Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=314 National Science Week: This years National Science Week celebration is from 13-21 August. Check out the more than 1000 events happening around the country on the website Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=313 Alzheimers Association: Since its debut during the Alzheimers Association® International Conference 2010, Alzheimers Association TrialMatch (www.alz.org/trialmatch) has matched more than 2,500 people in the US to Alzheimers clinical trials based on their diagnosis, preferences and location. The internet and phone-based service provides comprehensive clinical trial information and an individualized matching service for people with Alzheimers disease or related dementias, their caregivers, family members and doctors Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=312 Tufts: While the number of personalized medicines and companion diagnostics in use in the U.S. has gradually increased—from a handful in 2001 to several dozen in 2011—surveys conducted by Tufts CSDD show that lack of evidence concerning the clinical usefulness of many current companion diagnostics is a major factor limiting the potential of personalized medicine Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=311 The Times of India: Nearly a month after the licence of Axis Clinicals was suspended for irregularities in conducting trials on poor illiterate women, officials of the Drug Controller General of India (DCGI) found similar violations by nine CROs in the state Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=310 Govt Media Release: Acting Minister for Health and Ageing Mark Butler today announced that Dr Andrew Refshauge has been appointed as the new Chair of the Australian Institute of Health and Welfare (AIHW) for a three-year term Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=309 Mass Device: US Democratic party leaders ask editors of the New England Journal of Medicine, Archives of Internal Medicine and the Journal of the American Medical Assn. to rate studies used by medical device industry to support claims of inadequate FDA regulations Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=308 FDA: FDA is issuing this draft guidance to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=307 Mass Device: The FDA announced open registration for a series of workshops on the "adoption, implementation, and use of unique device identifiers (UDIs) in various health-related electronic data systems." The meetings will cover issues related to UDIs, a system for tracking medical devices in efforts to aid device recalls and other safety measures Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=306 EMA: The European Medicines Agency has updated the template for package leaflets for human medicines, to make the information easier for patients to understand and to include new sections on medicines benefits and their uses in children Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=305 ABC News: A new study from the Australian National University (ANU) has found those who have glandular fever antibodies have a much greater risk of developing multiple sclerosis. The research, published in the journal Neurology, could lead to new treatments for the condition Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=304 PharmaTimes: Australians seem to know more about the US FDA than their own pharma regulator, the TGA, and the FDAs information is as likely to be relied upon as that from the TGA, says an official government report. Related: 21Jul11 Medicines Australia: New report will help community understand TGA; 21Jul11 The Australian: TGA told to open up and get on front foot; 21 Jul 11 The Conversation: Business as usual… another review reports but will the TGA become more transparent 20 Jul11: TGA Transparency Review Released. Related: Media Release Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=303 Australian Senate: On 15 June 2011 the Senate referred the regulatory standards for the approval of medical devices in Australia, with particular attention to devices with high revision rates, to the Senate Community Affairs Committees for inquiry and report.The committees inquiry will be focussing on joint replacements. Submissions should be received by 29 July 2011. The reporting date is 12 October Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=302 Australian Senate: On 23 June 2011 the Senate referred the Government’s administration of the Pharmaceutical Benefits Scheme (PBS) to the Finance and Public Administration References Committee for inquiry and report by 18 August Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=301 DIISR Media Release: Some of Australias most innovative firms will showcase their wares on the global stage at the worlds largest biotechnology event - the BIO 2011 International Convention in Washington DC. As part of the continued push to promote Australian products and services in markets overseas, Innovation Minister Senator Kim Carr supported the delegation made up of representatives from industry, research and government Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=300 InPharm: Regulatory affairs personnel are key members of the cross-functional teams in pharma which manage products before and after launch. Article discusses how to get into regulatory affairs and what makes a good regulatory affairs executive Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=299 Archives of Internal Medicine - Abstract of paper which found a gabapentin (Neurontin) trial in the 1990s to be a marketing activity (seed study) rather than true research. Several blogs have commented on it Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=298 AIHW: This report presents the most up-to-date estimates of the number of people with diagnosed diabetes in Australia based on self-reports to the Australian Bureau of Statistics 2007-08 National Health Survey Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=297 Australian Life Scientist: The last 12 months has been one of tremendous ups and downs for Australian biotechnology companies, read about all the positives and negatives in this two part series from Australian Life Scientist. Australian Life Scientist Part Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=296 The (UK) Telegraph: A patient’s perspective on participating in a Cancer Vaccine trial detailing both her positive and negative view Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=295 PharmaTimes: Merck of the US has announced that it will voluntarily include the research protocol and statistical analysis plan among the materials it supplies to medical journals when it submits clinical study manuscripts for publication Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=294 DIISR Media Release: Inventors in Australia and New Zealand can look forward to a faster, cheaper and more streamlined trans-Tasman patent process, as announced today by Australia’s Innovation Minister, Senator Kim Carr, and the New Zealand Commerce Minister, Simon Power. The Ministers have agreed to an implementation plan that will deliver a single application process for both countries by early 2013, and a single patent examination by June Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=293 Medical News Today: The International Forum for Collaborative HIV Research has recommended worldwide pharmacovigilance measures to be undertaken for the use of antiretroviral drugs. Related:5 Jul 11 PLOS Medicine: Global Pharmacovigilance for Antiretroviral Drugs: Overcoming Contrasting Priorities Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=292 Cardiovascular Business: A perspective piece published in NEJM on June 8 argues that the FDA rule on judging relatedness of AEs in clinical trials —published last September and made effective March 28—clarifies the responsibilities of clinical investigators and IND sponsors in reporting unexpected events, and pushes more responsibility to the IND sponsor, rather than leaving judgments up to clinical investigators Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=291 ABC News: A world first trial of a fully automated artificial pancreas for diabetes patients is under way at Princess Margaret Hospital, Perth. The system involves two sensors that sit under the skin and measure glucose levels working with a mobile phone that calculates how much insulin to give and releases it using a pump Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=290 Ministerial Media Release: Two important milestones in the development of Australia’s e-health system have been met with the key appointment of the National Change and Adoption Partner and the release of the Personally Controlled Electronic Health Record System: Legislation issues paper. A consortium headed by McKinsey and Company has been selected to lead the national change and adoption process as Australia moves to introduce Personally Controlled Electronic Health Records (PCEHR) next year Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=289 Oncology News: Pharmaceutical companies expenditure on medical education slumped over 20% in the last half-year. The figures from Medicines Australia showed spending on sponsorship, including hospitality, fell by $7.7 million to $27.5 million from October 2010 to March 2011, compared with the previous six months. The average spent on hospitality per head was just $36.09 -- a fall of $6 on the previous six months. [Full article only available to subscribers] Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=288 EMA: In two policies published today , the European Medicines Agency has released its plans for granting public access to the information held in its EudraVigilance and EudraVigilance Veterinary databases of the potential side effects of human and veterinary medicines Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=287 PLOS Medicine, 12 Jul 11: Individualized Cost-Effectiveness Analysis, [In this essay, we aim to contribute to the discussion on how to use ICER and related metrics in a way that would be more useful for decision-making at the individual level, whether used by clinicians or individual patients. JCRBP:1 Jul 11 Let the (clinical trial) games begin A discussion of gaming and it potential application to various aspects of running clinical trials in order to make them more enjoyable Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=286 Department of Health and Ageing: Draft Terms of Reference for the Review have been released for discussion. The Government intends to announce the Review Panel and its Terms of Reference by the end of July 2011 and for a final report to be received from the panel by 31 August Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=285 Department of Innovation, Industry, Science and Research Media Release: Interested parties are being asked to comment on the R&D Tax Credit’s detailed administrative arrangements. Submissions on the consultation documents are due by 5 August Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=284 EMA: The European Medicines Agency has released a reflection paper on use of genomic markers in the development and testing of human medicines for public consultation. The paper is open for comments until 25 November Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=283 Pharmalot: A group of academic and industry experts has convinced the FDA to ease safety restrictions on clinical trials for Alzheimer’s drugs, which were imposed after a 2008 study of a developing med found cases of a brain-swelling condition known as vasogenic edema Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=282 Science Newsline: A new study by investigators from the University of North Carolina at Chapel Hill School of Medicine has confirmed the existence of a "trial effect" in clinical trials for treatment of HIV. Trial effect is an umbrella term for the benefit experienced by study participants simply by virtue of their participating in the trial Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=281 Cutting Edge Info Media Release: Per-patient clinical trial costs have risen an average 70 percent across all development phases since 2008, according to a new study by Cutting Edge Information Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=280 Jul 11: An update to Regulatory Framework for Biologicals became available via the Legislation part of the website. In addition, the Australian Regulatory Guidelines for Biologicals have been published, which provide sponsors, manufacturers, and the general public, information on the regulation of biologicals. 8 Jul11: The TGA and the USA FDA agree about problems at CSL Biotherapies. A statement from the TGA, released in consultation with the FDA, clarifying their views on the problems identified at CSL, any potential risk to the Australian and American public and the future management of that risk. 8 Jul 11: Australian pharmacovigilance guideline for sponsors. From the 1 October 2011 all medicines on the ARTG, whether registered or listed, will need to comply with the guideline entitled Australian Guideline for Pharmacovigilance Responsibilities of Sponsors of Registered Medicines Regulated by Drug Safety and Evaluation Branch. There has been no change in requirements for reporting requirements for registered medicines, but from 1 October, listed medicines will have the same requirements as for registered medicines. From 1 October 2011, all sponsors should report adverse events using MedDRA terminology. Clinical trial adverse drug reaction reports should continue to be handled according to the advice issued by the TGA, in July 2000 entitled Notes for Guidance on Clinical Safety Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95). Annotated with TGA Comments. 6 Jul11: Overview of the regulatory framework for in-vitro diagnostic medical devices. This document is intended to provide an overview of the new regulatory framework for in vitro diagnostic medical devices (IVDs) which came into play 1 Jul 2010. Under the framework, IVDs are regulated as medical devices, and the provisions of the Therapeutic Goods (Medical Devices) Regulations 2002 have been expanded to include IVDs. 5 Jul11: Indications for Listed medicines that refer to biomarkers. Indications and claims for biomarkers are permitted for listed medicines, but only in the context of maintaining normal levels in healthy persons. This page provides further guidance on what claims are acceptable and what evidence must be provided for those claims. 4 Jul 11: Labelling and packaging review. The TGA is initiating a review of the labelling and packaging regulatory framework and will include prescription medicines, over the counter medicines and complementary medicines. Consultation documents relating to this review are being prepared and will be released in due course on this website. 1 Jul 11: Changes to prescription medicine registration fees from 1 July 2011: Information on important changes to application and evaluation fees in relation to the registration of prescription medicines that will commence from 1 July 2011 30 Jun 11: Evaluation of a new medicine - The TGAs lifecycle approach to regulation: A summary of the objectives and processes for regulating new medicines Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=279 PharmaTech Talk: A new report jointly commissioned by EFPIA, EuropaBio, Medicines Australia and PhRMA examining HTAs has highlighted several areas for improvement. In particular, the report found little evidence that current HTA processes accelerate access to medicines or result in better rewards for medicines with high therapeutic values. Related: Medicines Australia Media Release, 13 Jul Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=278 OFR/ FDA: Establishing Performance Characteristics for Influenza Virus IVD Device Test 15 Jul 11 This guidance from the FDA is to inform industry and Agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for in vitro diagnostic devices intended for the detection or detection and differentiation of influenza viruses. IV Companion Diagnostic Devices:14 Jul 11 This guidance is intended to assist (1) sponsors who are planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic device (or test) for its safe and effective use and (2) sponsors planning to develop an in vitro companion diagnostic device that is intended to be used with a corresponding therapeutic product Mon, 25 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=277 The Australian Government today released the report of the Therapeutic Goods Administration (TGA) Transparency Review panel, chaired by Professor Dennis Pearce. Click here to view the report Wed, 20 Jul 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=258 Dept Health & Ageing Media Release: Australian consumers and health professionals will have more ready access to generic medicines following the passage of legislation through the Senate today. The Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 will ensure originating pharmaceutical companies can no longer use copyright of product information to delay or prevent generic medicines entering the market Wed, 15 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=276 DIISR Media Release: An external review of the Innovation Investment Fund (IIF) program has given it the thumbs up. To date the IIF program has committed a pool of $524 million of government and private capital to invest in promising early-stage companies Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=275 nbsp; Trials Journal, 9 Jun 11:Social validity of randomised controlled trials in health services research and intellectual disabilities: a qualitative exploration of stakeholder views. (Examines the individual perceptions of RCTs in 18 carers, 6 service users and 27 professionals Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=274 ComLaw: The complete SR 2002 No. 236 Regulations as amended, taking into account amendments up to Therapeutic Goods (Medical Devices) Amendment Regulations 2011 (No Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=273 MTAA: MTAA invites submissions from interested parties who would like to contribute to the review. Submissions and/or comments are being invited by the MTAA from the healthcare sector, government, consumer groups and the medical technology industry as part of the 3 yearly external review of the Code. The review will lead to a revised edition of the Code in Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=272 Lexology/Piper Alderman: Whilst the introduction of section 25A the Therapeutic Goods Act 1989 (Act) has improved the protection afforded to innovator companies for intellectual property relating to their new products, it is important for sponsors to understand that there are specific criteria to be met for data exclusivity to apply Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=271 Lexology/Piper Alderman: This article considers what information may be taken in the review of decisions of the TGA, particularly in light of recent changes to the legislative definition of “new information”. Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=270 PharmaTimes: Less than a month after it announced a definitive agreement to acquire fellow US-based contract research organisation Kendle International for around US$232 million in cash, INC Research has bulked up its Asia Pacific presence by taking over Australia’s Trident Clinical Research Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=269 Dept Health Ageing Media Release: Australian Health Ministers met in Melbourne today and reached in principle agreement on legislation to establish the National Health Performance Authority as the next stage of national health reform Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=268 PharmExec: FDA’s Center for Drug Evaluation and Research (CDER) has created a new office “dedicated to addressing the challenges of globalization and an increasingly complex drug supply chain”. The new Office of Drug Security, Integrity & Recalls (ODSIR) will “take the lead in dealing with issues such as supply chain security, counterfeit and diverted drugs, economically motivated adulteration, import operations, and drug recalls” Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=267 TGA News: The regulatory framework for biologicals commenced on 31 May 2011. All products within the scope of the framework need to comply with the requirements made under the new legislation, which include a 3 year transition period. It is recommended that sponsors of biological products submit an application to the TGA to include their product in the ARTG before 30 November Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=266 NEJM Perspective:The FDA recently published a regulation establishing a new safety-reporting paradigm for drugs being studied under investigational new drug applications. This rule — published last September and effective as of March 28, 2011 — is one in a series of steps the FDA is taking to enhance the protection of human subjects and improve trial conduct by streamlining the regulatory procedures for clinical trials Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=265 Securing Pharma: Now that the dust has settled on the European Parliaments approval of the Directive on Falsified Medicines - and the May 27 ratification by the Council of the European Union - attention is turning to the tricky process of implementing the measures within it Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=264 Media Release: The Australian Competition and Consumer Commission, Cancer Council Australia and the TGA are urging Australian women not to rely on unproven commercial breast imaging technologies to detect breast cancer Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=263 TheHeart.org: delete this link as I could not get in The French drug regulatory authority, AFSSAPS, has suspended the marketing of pioglitazone (Actos, Takeda). The decision was made after a study requested by AFSSAPS confirmed a small increase in bladder cancer among patients treated with the diabetes drug. Related: EMA Media Release 9 Jun 11: Update on ongoing European review of pioglitazone–containing medicines Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=259 The Australian: Consumers, medical providers and IT experts have have widely condemed the Gillard governments plans for setting up the $500 million personally controlled electronic health records program. Their responses to the draft plan - released in April by Health Minister Nicola Roxon - became public this week, and most slammed it as impractical, unsafe and a waste of money. The Society of Hospital Pharmacists of Australia (SHPA) speaks out in support of the PCEHR: 7 June 11 SHPA Media Release: SHPA President Sue Kirsa has welcomed the fact that pharmacists, along with all other health professionals now stand on the threshold of being able to access health information that will support them to provide better and safer health care. PCEHR deadline too tight, says MSIA: 8 June 11 The Australian: The Medical Software Industry Association says the "extremely tight" July 2012 deadline for the start of the $500 million personally controlled e-health record program risks patient safety as there is little time to ensure new software is free of bugs. Related: PCEHR draft operations out in August: 9 June 11 The Australian: A revamped version of the draft concept of operations for the $500 million personally controlled e-health record will be issued in August, after the federal Health department was swamped by late submissions. A total 144 submissions have been received following an extension of the deadline by one week to June 7. Only 11 submissions had been received by the original deadline Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=257 Forbes: PatientsLikeMe, an online health data sharing platform, has come up with a new intuitive clinical trial search engine that enables patients to enter their illness, age, and zip code and get a list of clinical trials into that they can enter. (US centres only Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=262 Science Media Centre NZ: On Wednesday Health Select Committee released the report, ‘Inquiry into improving New Zealand’s environment to support innovation through clinical trials’. Mainstream and specialist media outlets have reported on the inquiry findings, providing commentary and analysis on the committee’s recommendations Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=261 Applied Clinical Trials: Pfizer Inc. is conducting the first-ever randomized clinical trial under an investigational new drug (IND) application that manages study participation entirely using electronic tools allowing patients to participate in the clinical trial regardless of their proximity to clinical sites. The pilot project, initiated following review from the US FDA, uses mobile phone and web-based technology to collect necessary data for the trial without clinic visits. Related: SBS News 8 Jun11: Drug firms go online to test and sell medicines; WSJ 7 Jun 11: A Clinical Drug Trial Via Phone, Computer Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=260 Mass Device: The U.S. Food & Drug Administration took its first step into the uncertain world of nanotechnology regulation by releasing draft guidance on how regulatory bodies should handle the tiny tech Tue, 14 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=255 nbsp; Journal of Clinical Research Best Practices, May 11. Clinical Research Industry Trends (Survey that suggest the industry is healthier now than it was in the first quarter of 2010) Journal of Clinical Research Best Practices, May 11. Making Sense of Biostatistics: Missing Data in Clinical Trials (A discussion of the challenges presented by missing data whic reduces the power of a study and is a major source of potential bias when interpreting study results Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=254 DIISR: The National Survey of Research Commercialisation (NSRC) is a survey of research commercialisation inputs, activity and outputs for Australian publicly funded research organisations (Universities, Publicly Funded Research Agencies and a range of Medical Research Institutes). The report of the fifth iteration of the survey - covering the years 2008-09 - is now available (released May Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=253 TGA: Update to 2004 document to reflect regulatory changes. The purpose of this document is to describe the broad risk management approach adopted by the TGA to regulation of therapeutic goods Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=252 TGA: The TGA is conducting a second round of three-hour workshops on the streamlined submission process in Brisbane (1 June), Melbourne (6 June), and Sydney (8 June). These sessions will be run through ARCS Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=251 TGA: These new guidelines have been developed to provide information about the process of obtaining and maintaining GMP clearances for the manufacturing steps of medicinal products including Active Pharmaceutical Ingredients (APIs) that are carried out overseas. They describe the approach of the TGA to granting GMP clearances in relation to these manufacturing steps and the documentation required for the assessment of applications Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=250 The Australian: From July, patients living in remote, regional and outer metropolitan areas will have access to video-conference consultation with doctors based in city hospitals. Although the details arent final, theres $120.5 million in the budget to fund new Medicare rebates for telehealth services Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=249 TGA: The TGA announces arrangements for senior staffing of TGA Offices, with effect from 16 May Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=248 Croakey Health Blog: A discussion of alternative methods to cut PBS spend beside deferring PBS listing of medicines approved by the Pharmaceutical Benefits Advisory Committee Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=247 EMA: The European Medicines Agency today published a meeting report reflecting discussions and comments made on its draft reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the European Medicines Agency. A number of participants called for marketing applications to include more information related to clinical trial ethics and said that applications should be rejected if there are serious violations Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=246 SF Gate: Michael J Fox advocates for increased clinical trial participation and shares examples of how the Michael J Fox foundation hopes to help, including launching a web-based tool to proactively alert people to trials in their area, and advocating a range of ideas to increase awareness and participation in clinical trials: from tax incentives to employer programs to bringing the trials to volunteers, to spurring doctors to encourage patients to participate in trials Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=245 Mass Device: Medtronic, Inc. will carpool with one of the worlds largest automakers to bring continuous glucose monitoring to Ford automobiles, for drivers with diabetes Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=244 DukeHealth.org: A public-private partnership comprising over 60 organizations has announced recommendations to improve clinical trials by ensuring quality with effective and efficient monitoring and improving safety through better methods of reporting unexpected serious adverse events to investigators. The recommendations are the first to be issued by the Clinical Trials Transformation Initiative (CTTI Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=243 FDA.gov: FDA Science Board Subcommittee presentation submitted to the FDA Science Board 20th May, with a discussion of goals and scope for the review, and recommendations made Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=242 The Sunday Telegraph: The TGA conducted more than 200 audits of complementary medicines between July 2009 and December 2010, and found several hundred instances where medicines failed to comply with regulations Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=241 eMonthly Prescribing Reference: A multicenter pediatric pain clinical trials consortium will facilitate better study design and ensure children experience no additional burden for participation in research, including enduring even slightly undertreated pain, a panel of pediatric pain experts said during the American Pain Societys 30th Annual Scientific Meeting Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=240 PLOS Medicine, 24 May 11: Medical Students Exposure to and Attitudes about the Pharmaceutical Industry: A Systematic Review [Conclusion: Undergraduate medical education provides substantial contact with pharmaceutical marketing, and the extent of such contact is associated with positive attitudes about marketing and skepticism about negative implications of these interactions. More research is needed.] Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=239 Research Australia: The Research Australia Awards recognise the great leaders and innovators, philanthropists, advocates and researchers that contribute to improving the health and lives of all Australians. Nominations are open until 15 Jun Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=238 TGA: Describes the role, membership, terms of references, meeting and summary of achievements for the RegTech Forum, a forum to enable effective discussion and consideration of issues, relevant to the medical devices sector, that are of a regulatory or technical nature. Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=237 Publish in Medicine: An interview with Prof. Doug Altman, director of Centre for Statistics in Medicine (CSM) in Oxford and the Medical Statistics Group at Cancer Research UK, statistical advisor for the British Medical Journal, co-convenor of the Statistical Methods Group of the Cochrane Collaboration, and steering group member of the EQUATOR Network about research reporting guidelines Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=236 MJA Insight: Doctors are concerned that pharmaceutical industry support for continuing professional development creates bias, but are not prepared to pay to reduce this influence, according to a US study, published in Archives of Internal Medicine. 88% believed commercial support introduced bias, but only 42% were willing to pay higher medical education course registration fees to decrease or eliminate this support Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=235 Chicago Tribune: Recipients of life-saving products may not know of potential conflicts of interest when doctors put their own inventions to use. This article discusses the issue of physicians conflicts of interest as demonstrated by the case of hundreds of people who received annuloplasty rings to treat their valve disease prior to FDA approval Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=234 The Cochrane Library: A series of public lectures covering various issues related to clinical trials held on International Clinical Trials Day in Austria, sponsored by ECRIN Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=233 EMA: The European Medicines Agency has responded to an article published in the British Medical Journal (BMJ) that called for more transparency by medicines regulatory authorities Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=232 FDA: A new draft Guidance has been released re Financial Disclosure by Clinical Investigators and includes a Q&A about the regulations, forms and what is subject to regulation Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=231 InHealth: Two-thirds of small medical device and diagnostic companies––the drivers of innovation in the sector––are obtaining clearance for new products in Europe first, suggesting delayed market entry in the U.S., according to a comprehensive industrywide survey about FDA’s 510(k) product review process by researchers at Northwestern University Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=230 TGA: Professor John Horvath has reviewed the use of influenza vaccines in Australia and our system for reporting adverse events following vaccination. Report and Media Release now available Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=229 The Age: Former chief medical officer John Horvath has called for major changes to the way vaccines are monitored in Australia after 100 children had febrile convulsions after Fluvax shots Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=228 TheWest.com.au: WA health experts yesterday savaged the Health Departments widespread acceptance of travel and accommodation paid for largely by pharmaceutical and technology companies, claiming the benefits for patients were difficult to see Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=227 FDA Media Release: The US FDA today announced that it is disclosing more information about inspections and court actions, and now has a Web portal on its enforcement activities as part of Phase II of the agencys Transparency Initiative Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=226 WA Today: The federal governments response to a large number of adverse reactions to the flu vaccine last year has been deemed appropriate by an independent auditor. Related: Weekend Australian 28 May 11. Virus in the System: By the time flu vaccines were banned for kids under five last year, their side effects were being felt around the country. What went wrong Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=225 The Australian: In investing, timing is everything. And yesterday the talk of the market was how Pharmaxis chief executive Alan Robertson managed to sell 500,000 shares in his company at $2.95 on May 17 at the very top of the market Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=224 The Australian: UNICEF posted on its website on Friday the actual prices it has paid individual drug makers for 16 vaccines bought over the past decade. It is for the first time publicising what drug makers charge it for vaccines in efforts to spark price competition in the face of rising costs Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=223 A Propaganda Index for Reviewing Problem Framing in Articles and Manuscripts: An Exploratory Study. Data showed that there was a high rate of propagandistic problem framing in reports of RCTs regarding social anxiety. Concludes this propaganda index warrants further exploration as a complement to reporting guidelines such as CONSORT and PRISMA Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=222 The Daily Telegraph: The number of children aged six and under being prescribed anti-depressants has soared by almost 50 per cent since the federal government pledged to investigate the issue, new figures show. Five deaths have been linked to anti-depressants in children aged 10 to 19 since 2009, TGA figures show Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=221 DIISR: A statement from the minister on the “Excellence in Research” process and approved set of enhancements recommended by the ARC that deal substantially with sector concerns while maintaining the rigour and comparability of the ERA. Related: ARC Media Release 30 May 11: Excellence in Research for Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=220 ComLaw: A number of new provisions have been added to the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations to establish and implement a new regulatory framework for biologicals. The new regulatory scheme commenced on 31 May 2011. Section 32A of the Act includes a definition of biological for the purposes of the Act. This Determination sets out therapeutic goods that are not biologicals for the purposes of Part 3-2A of the Act Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=219 EMA: A report written by an independent expert has highlighted a number of recommendations to help improve the European Medicines Agencys communication on the benefits and risks of medicines Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=218 JCRBP: This article highlights certain practices for IRBs to avoid in the interest of improving the efficiency and responsiveness of the human research protection program. (A US perspective Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=217 EMA: The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have published the ENCePP guide on methodological standards in pharmacoepidemiology, an important tool that reviews and gives direct electronic access to the main existing methodological guidance for research in pharmacoepidemiology and pharmacovigilance Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=216 Life Science Leader: Highlights from a two-day Post-Approval Summit in Boston where speakers presented a range of ideas for how researchers can get even more, better data and refine it into information that plays a role in decision-making by regulators, biopharma, physicians, insurers, and patients, ultimately improving health outcomes Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=215 Review of the Australian Regulatory Guidelines for Over-The-Counter MedicinesThe TGA has begun a project which will review and amend the current Australian Regulatory Guidelines for Over-the-counter Medicines (ARGOM), published in 2003. This project will bring the ARGOM up to date to reflect the current TGA regulatory environment and business practices for over-the-counter (OTC) medicines. New version of the Australian regulatory guidelines for prescription medicines to be released, and Appendix 8 of the ARGPM has been updated in May 2011. Product Information: The Restricted Medicine Specification 2011 lists the medicines or classes of medicine that are to be restricted medicines for which a draft PI (product information) document is required as part of the submission dossier. Information on lodging an application for a new registered complementary medicine. Prescription medicine BPR update newsletter, May 2011 - provides an update on the streamlined submission process. TGA Clinical Trials Audits, Release of Therapeutic Goods and Quality Risk Management Presentations Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=214 Life Science Leader: A panel which included regulators from Europe and Canada, US and European industry representatives and US academia recently described an array of activities and safety initiatives by their respective governments to improve the utility of findings from post-market research and/or communicating them to patients Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=213 MedCity News: A recent analysis by the Centre for Medicines Research in the UK has concluded that since 2008, the failure rate for drugs in Phase II and III clinical trials has been rising. Phase II success rates are currently at 18%, lower than at any other phase of drug development Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=212 Drugs.com: A physician and a clinical research coordinator have been indicted on charges of falsifying study data in a clinical drug trial. The employees of the Lee Research Institute in Johnson County, Kan have been charged with one count of conspiracy, three counts of mail fraud, and one count of falsifying information required by the FDA, allegedly between January to May Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=211 Dept Health & Ageing Media Release: The final, detailed national agreement on health reform is expected to be signed off at COAG in July Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=210 The Australian: Ernst & Young has been secured by the Health department for the Gillard governments $467 million personally controlled e-health record program, winning a $990,000 contract to provide "external delivery assurance adviser" services over the next 14 months Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=209 The Australian: A national register of multiple sclerosis patients undergoing stem cell therapy will allow researchers to quickly home in on the most effective treatments. The register, based in Perth and run by Multiple Sclerosis Research Australia, will provide data on the different techniques used and what the outcomes were Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=208 Bloomberg: A Johnson & Johnson unit was ordered by a South Carolina judge to pay more than $327 million in penalties for deceptively marketing the antipsychotic drug Risperdal as safer and better than competing medicines Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=207 The Australian: The Gillard government is under increasing pressure over its decision to delay subsidies for new medicines after a patient died waiting for it to subsidise a $2000-a-week bowel cancer drug Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=206 The Australian: A Senate inquiry has found the introduction of a national medical registration body (the Australian Health Practitioner Regulation Agency) was a "debacle" that resulted in doctors being unknowingly deregistered and losing income and patients being left without healthcare. Mon, 06 Jun 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=205 ABC News: The Articular Surface Replacement hipwas sold to doctors and patients as a giant step forward in joint replacement. Now there are laims that the metals hips are disintegrating and making patients sick Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=204 PLOS One, 19 Apr 11: Distribution of Country of Origin in Studies Used in Cochrane Reviews (The USA and the UK lead in publishing clinical papers. The emerging role of China can be seen, particularly related to CAM studies. Taking into account size of population and economic power, countries like France, Germany, Italy, and Spain provide small contributions. In contrast, smaller countries like Australia, Denmark, Finland, Ireland, New Zealand, and Sweden also play major roles Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=203 InVivo Blo: A discussion of sessions from the recent European Generics Associations International Symposium on Biosimilar Medicines in London which drew the conclusion that biosimilars havent really lived up to expectation, a least yet Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=202 NPR: For the first time in 27 years, the guidelines clinicians use for diagnosing Alzheimers disease have changed, emphasizing earlier detection and biological tests for the illness Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=201 Wall Street Journal: A new clinical trial published in Nature Biotechnology found that lithium didnt slow the progression of Lou Gehrigs disease. But the findings released Sunday also showed that the use of a social network to enroll patients and report and collect data may deliver dividends for future studies. Related: Nature Biotechnology 24Apr11: Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithm Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=200 CentreWatch: The number of principal investigators (P.I.s) filing 1572s worldwide has declined sharply, according to new data from the Tufts Center for the Study of Drug Development (CSDD). CenterWatch recently reported that the number of clinical trials initiated after late 2008 dropped by 40%, so the decline in 1572s follows suit. The good news, though—an uptick is likely on the horizon Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=176 The Age: An explosion of medical research fraud underlines the wisdom of boosting public funding for research to reduce dependence on drug company money Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=178 Medical News Today: The fact that the 2011 Budget had no PBS price-related savings measures, as per the MOU between Medicines Australia and the Government, has been welcomed by Medicines Australia, although they continue to disagree with the Cabinets decision to block the listing of new medicines on the PBS, contradicting the intent of the MoU Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=177 SafeMedicines.org: Australian customs officials in Queensland have stopped 288 packages containing counterfeit medications in the past twelve months, an increase of 7 fold from the previous year Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=181 Ministerial Press Release: The government justifies their $2.2 billion mental health package which will provide invaluable assistance to young Australians who suffer from a mental illness Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=187 NY Times: Federal regulators are investigating Google on suspicion of illegally displaying ads for online pharmacies that are operating outside the law, government officials said Thursday Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=188 ComLaw: The purpose of this instrument is to specify medicines or classes of medicine for the purposes of the definition of restricted medicine in subsection 3(1) of the Therapeutics Goods Act 198, per Schedule 1 to the instrument. The effect of the inclusion of a medicine or classes of medicine in Schedule 1 is that an applicant for registration of any of the medicines so listed is required to provide a draft product information document as part of the application for registration package. Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=193 FDA: An explanation of the legislative instruments used to increase the availability of paediatric drug information, and the benefits for drug sponsors Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=194 RedOrbit: Physicians are struggling to translate clinical research into everyday practice. A new study shows that medical therapy from a widely publicized clinical trial was applied less than half the time to heart stent patients Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=198 Pharmalot: An investigation by Indias health ministry has found that drugmakers running clinical trials in the country have not compensated survivors of most volunteers who died during their studies. The health ministry has asked 44 drugmakers to explain why they have not provided compensation, which is mandatory under the current law. Among those queried were Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson and Sanofi-Aventis Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=192 Kru Research: Lisa Emrich, empowered patient and e-patient blogger, speaks candidly and explains what she wants and expects from interacting with pharma: Information and the feeling that somebody actually cares Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=190 PMLive: European pharmaceutical promotion spend increased by 0.5% in the top five developed markets of France, Germany, Italy, Spain and the UK and 2.2% in the rest of Europe in the 12 months up to and including September 2010. North American promotion expenditure declined, down by 10.3%, while in the rest of the world expenditure expanded by Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=199 PharmaTimes: Growing implementation of adaptive clinical trials following the publication of draft guidance on adaptive designs by the US Food and Drug Administration in February 2010 is helping to ease regulatory concerns within industry about the approach, says Perceptive Informatics on the basis of the results from its recent global survey on plans for adaptive study designs Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=197 Reuters: Today, the clinical trials business has gone global as drugmakers seek cheaper venues for studies and cast their net further afield for big pools of "treatment-naive" patients who are not already taking other drugs that could make them unsuitable subjects for testing new ones Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=196 Economic Times (India): Setting a target of doubling bilateral trade in five years, India and Australia on Thursday agreed to start talks on a comprehensive free trade agreement (FTA) in June. India mainly exports machinery & equipment, clothing, diamonds, iron and steel products and medicines to Australia Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=195 GaBi Online: On 27 April 2011, the FDA announced that it is working with the EMA and TGA to finalise a permanent pilot programme for joint good manufacturing practice (GMP) inspections at active pharmaceutical ingredient (API) manufacturing facilities. The objective of the collaboration on GMP inspections is to spread the workload, allowing more API sites to be monitored Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=191 FDA: So far in 2011, FDA has approved more than 150 new brand name and generic drug products. “Spotlight on Drug Innovation” summarizes the latest new novel drugs approved in Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=189 CentreWatch: The FDA has passed nearly twice as many biopharmaceutical drug approvals in the last 10 years than it did in the 1990s, a news release from the Tufts Center for the Study of Drug Development (CSDD) has indicated, according to Mass High Tech Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=186 ABC News: Nine medical institutions in Sydney have launched a joint recruitment drive to get more people into clinical trials Tue, 17 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=185 Qld Health: The second edition of Queensland Heaths Research ethics and governance eNewsletter has been released and includes an overview of the changes regarding submission of multi-centre studies to a reviewing HREC (including signing of an MOU for mutual recognition of ethical approval in NSW, QLD and VIC in public heath organisations) and an introduction to the Queensland Health Database of Research Activity (DoRA), which is now live Mon, 16 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=184 The Australian: The TGA has told GPs to stop giving patients a second dose of a vaccine that protects against pneumococcal disease (Pneumovax 23), after more than 80 Australians suffered severe reactions, including severe swelling and abcesses. Related: TGA Media Release, 16 Apr 11 and, TGA Media Release 17/19 Apr Mon, 16 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=183 The Australian: Australias biggest maker of prescription drugs, Alphapharm, warns it may stop supplying four products to the taxpayer-funded medicines program after the government ignored expert advice to increase the price it pays to buy them Mon, 16 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=182 The Australian: GSK will reveal next month how much money it pays to doctors, health groups and research institutes in grants and fees -- a first step that could eventually allow patients to tally payments to their own doctors Mon, 16 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=180 Ministerial Press Release: In the March quarter 2011, a total of $4.0 billion was paid in Medicare benefits for 78.7 million services. This represented 3.5 services and about $175 in benefits for every Australian Mon, 16 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=179 NineMSN: Under draft laws passed by parliament on Wednesday, product information on generic drugs cannot breach copyright held by companies whose similar drugs have already been approved by the TGA Mon, 16 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=175 Sydney Morning Herald: Product safety studies must be made transparent Mon, 16 May 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=151 The Guardian: The budget contains plans for a unified Health Research Regulatory Agency to streamline the regulations on clinical trials, and so make them cheaper and easier to run. Related: 24 Mar 11 Evening Standard: Biotechs boosted by relief on R&D and changes to clinical trial rules. The biotech and small pharma industry was today celebrating a shot in the arm from yesterdays Budget, with higher tax relief on research and development plus changes to clinical trial regulation. The UK government report “The Plan for Growth” is located at http://cdn.hm-treasury.gov.uk/2011budget_growth.pdf. Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=154 Biotechnology News: Six senior industry figures have written an open letter to Australia’s federal senators and members of parliament, arguing that investment in medical research saves lives and money. The original letter is included here: Open_Letter_MPs_and_Senators_March_23.pdf(1.44MB). Related: The Australian: Revolt at research fund cut. The threat of a $400 million cut by the federal government to the National Health and Medical Research Council -- a move that could trigger a fresh brain drain -- has sparked a revolt by the countrys top medical researchers. A copy of a campaign initiated by the Walter and Eliza Hall Institute of Medical Research appears here: Research_funding(677.58kB Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=172 Scientific American: Health Care Myth Busters: Is There a High Degree of Scientific Certainty in Modern Medicine? Two doctors take on the health care system in a new book that aims to arm people with information. Science - CTSciNet: Learning How to do Cancer Clinical Trials. One doctor’s journey into clinical trials. Lancet: Romania plans changes to clinical trials system. Doctors in Romania are up in arms about draft government legislation that would see their payments for undertaking clinical trials in the country severely cut, and could spell an end to clinical trials in the country Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=171 Reuters: U.S. prices for brand-name drugs are rising faster than ever as patents expire on top-selling medicines and the pharmaceutical industry nervously eyes the future of healthcare reform Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=170 DIA Daily: The Kiowa County (KS) Signal (3/25, Pipes) reports that the biopharmaceutical research has declined in the last decade, and in response "the Obama administration announced last week that the new National Center for Advancing Translational Sciences (NCATS) will open its doors in October." The Signal adds that "NCATS, a billion-dollar-a-year program operating under the auspices of the National Institutes of Health (NIH), will work directly on new drug development." While, the "Obama administration and especially the NIH director, Dr. Francis Collins, hope NCATS will reinvigorate what they see as a private-sector lag," it does not address the real issue, which is the nature of government policy Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=169 TGA: A slide presentation given at recent public meetings about the transparency review Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=168 Red Orbit: When presented with different terms to describe a clinical trial, parents were far more likely to consent to enroll their child if it was called a "research study" than if it was called a "medical experiment" or a "research project," in large part because they perceived the former as safer, even though that was not necessarily the case, according to a report in IRB: Ethics & Human Research Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=167 GxP perspectives: A blog post discussing the main changes in the recently updated version of the Compliance Program Guidance Manual, CP 7348.810, Sponsors, Contract Research Organizations, and Monitors (CPGM), an FDA guidance document which gives instructions to FDA personnel on how to conduct an inspection of a sponsor or CRO involved in FDA regulated research. The article has links to all the relevant guidance documents Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=166 Vic BioPortal: More than two-thirds of the NHMRC’s $107 million worth of program grants were awarded to Victorian-based organisations, including the Walter and Eliza Hall Institute (WEHI), the University of Melbourne and the National Stroke Research Institute Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=165 SciBlog: According to scientists, “big pharma” representatives and the chair of the health select committee, National MP Dr Paul Hutchison, our approach to clinical trials threatens to see us lose out to other countries that are better serving companies that want to test their drugs and treatments. Includes podcast of the clinical trials discussion at NZ Bio Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=164 The Pink Sheet: FDA, the European Medicines Agency and Australian Therapeutic Goods Administration intend to make permanent a pilot program allowing for joint facility inspections. (Full article only available to Pink Sheet subscribers Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=163 Pharmalot: A discussion of clinical research investigator responsibilities in the context of a recent FDA warning letter to a doctor who failed to show proper oversight Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=162 Government Press release: Developing countries experiencing a health crisis will now be able to buy vital medicines from Australia at a more affordable price. Innovation Minister Senator Kim Carr and Trade Minister Dr Craig Emerson today announced that the Government would introduce legislation to allow Australian courts to grant compulsory licences to manufacture and export patented pharmaceuticals to countries trying to deal with epidemics and other types of health crises Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=161 Mass Device: Cardiologist blogger Dr. Westby G. Fisher considers the implications of a medical device maker suing a doctor and hospital who conducted a clinical investigation for the company Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=160 EMA: EU public clinical trials register gives access to information on clinical trials approved in Europe Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=159 Science Daily: Current rules requiring researchers to obtain consent for patients to take part in clinical trials in emergency situations are causing life-threatening delays to treatment, experts have argued Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=158 Open Australia: The speech introducing of the second reading of the above Bill into parliament. This bill will make changes to the Therapeutic Goods Act 1989 to further enhance the regulatory framework for therapeutic goods and provide additional support for the new streamlined processes being implemented to bring improvements to the time within which prescription medicines are evaluated by the TGA. Debate on the Bill was adjourned Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=157 RAPS: The US Supreme Court ruled this week that investors may sue drugmakers for securities fraud based on failure to disclose reports of adverse events, even if those events do not meet the standard of statistical significance Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=156 RAPS: The devastation produced by the earthquake, tsunami and subsequent nuclear crisis in Japan has affected drug and medical device companies there along with just about every other aspect of Japanese life. As life sciences companies and regulators assess the damage and formulate next steps, companies are scrambling to determine the impact on their operations, including manufacturing, supply chains and ongoing clinical trials Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=155 The Australian: The Australian Privacy Foundation has accused Health Minister Nicola Roxon of reneging on her promise to consult with consumers over the design and operation of the $467 million e-health record project Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=153 Medicines Australia: The price of generic medicines on the Pharmaceutical Benefits Scheme is already being reduced by as much as 70 per cent, despite claims in this morning’s press to the contrary, Medicines Australia chief executive Dr Brendan Shaw said today Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=152 Nine News: The federal government will pay $67.5 million in compensation to Pan Pharmaceuticals customers and service providers who lost money because of the companys closure Tue, 29 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=150 Trials Journal, 18 Mar 11: Designs for clinical trials with time-to-event outcomes based on stopping guidelines for lack of benefit (The authors suggest the new models proposed hold considerable promise for speeding up the evaluation of new treatments in phase II and III trials). PLoS Med, 15 Mar 11: The Challenge of Discharging Research Ethics Duties in Resource-Constrained Settings. (The paper on a Ugandan study illustrates the challenge of conducting research in resource-constrained settings and highlights two ethical conundrums: (1) should research be conducted in a setting if the existing standard of care for the health issue under investigation is “no treatment,” despite efficacious treatment existing elsewhere? and (2) should investigators introduce an efficacious standard of care in a setting if it would not otherwise be available?) Trials Journal, 15 Mar 11: Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (5 key aspects of trial design and conduct that were hindering recruitment were identified and an action plan implemented. Authors conclude qualitative investigations can be used to elucidate challenges to recruitment in trials with very different treatment arms, but require sufficient time to be undertaken successfully Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=149 A concept paper on the development of medicines to prevent HIV infection has been released for a two-month public consultation period. The concept paper is open for comments until 30 April 2011 Adjusted fees will be coming into effect on Friday 1 April European Medicines Agency launches its geriatric medicines strategy The first qualification opinion for a clinical biomarker has been released for public consultation. The biomarker is intended to identify patients who can be recruited for clinical trials of treatments for pre-dementia Alzheimers disease Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=148 EurActiv: An interview with Brian Ager, as he leaves the position of Director-General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) after 16 years, where he reflects on his tenure and discusses some of the new legislation and controversies affecting the pharmaceutical industry Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=147 MedConnect: In a study of 1,220 women analyzed for the period of 2001-2008, those in a clinical trial were more likely to stay connected with the system and followed by their treating physician, and had a significant survival advantage, increasing overall survival from 26% to 31% at 5 years (P = .000). The benefits of clinical trial involvement cut across the entire health care team Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=146 Media release: The Clinical Trials Honour Roll aims to celebrate the diversity of people and organisations that contribute to clinical trials each year. Nominations are open from 15 Mar – 17 May, with all appropriate nominees receiving certificates of participation and being listed on the Honour Roll, published 20th May for International Clinical Trials Day. The most nominated individual in Australia with receive special recognition in an award sponsored by ARCS Australia Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=145 PM Live: US pharmaceutical companies spent an unprecedented $67.4bn in 2010 on researching and developing new drugs and vaccines, according to Pharmaceutical Research and Manufacturers of America (PhRMA), $1.5bn higher than the 2009 total Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=144 Business Standard: The Union health ministry has constituted a taskforce to address issues faced by the pharmaceutical industry and evolve a long-term strategy for the sector Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=143 Medical News Today: New Medicare Australia data shows that expenditure on the Pharmaceutical Benefits Scheme is growing more slowly than at any time in the last 15 years, Medicines Australia chairman Will Delaat said in his annual State of the Industry Symposium address at the APP conference Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=142 TGA: The posting of this job in the Monitoring and Compliance area of the TGA, which includes responsibility for clinical trial audits suggests the clinical trial auditing function of the TGA is coming to fruition Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=141 ADIA Media Release: The Australian Dental Industry Association (ADIA) has given a qualified tick of approval to the way in which the Therapeutic Goods Administration (TGA) communicates its regulatory processes and decisions Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=140 Top news: According to a small study published in The Lancet Neurology, an innovative gene-insertion treatment for people suffering from Parkinsons disease has led to improvements in the condition for people on whom drugs hardly had any effect Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=139 CHF.org.au: Results of an online survey of consumers conducted by UltraFeedback in March 2011 into what people knew of the TGA Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=137 PR Newswire: The American College of Radiologys Imaging Network (ACRIN) and the Eastern Cooperative Oncology Group (ECOG), National Cancer Institute (NCI) Clinical Trials Cooperative Group members, today announced their intent to merge their clinical cancer research programs Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=138 The Australian: A new book launched today "How Safe is Your Prescription", claims medicine-related deaths are killing more people than heart attacks or cancer, thatone in three prescriptions checked by a medication screening program had an error, that about 190,000 hospital admissions a year are associated with medicines and their harmful side effects and the inappropriate use of medicine is costing Australia about $660 million a year Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=136 CenterWatch: An interview with Stephen L. Klincewicz, global head of drug safety for Bayer Consumer Care, in advance of Marcus Evans’ upcoming Global Pharmacovigilance and Adverse Event Reporting Forum, May Mon, 21 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=135 New York Times: As a medical student and later during my residency, I trained for some time in a medical center known for its research and clinical trials. Every week, patients with rare diseases and cancers that had not responded to standard therapy arrived from all over the country, eager to try something new, even if the efficacy of the treatments had not yet been proven Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=134 The AP (3/11, Cheng) reports that an "expert panel commissioned by the World Health Organization to investigate its handling of the swine flu pandemic has slammed mistakes made by the UN body and warned tens of millions could die if there is a severe flu outbreak in the future." The committee issued a draft report on Thursday regarding the 2009 global swine flu outbreak, stating that WHO made some critical errors. The AP adds that the "group described WHOs definition of a pandemic and its phases as needlessly complex, criticized the agencys decision to keep the members of its advisory committee secret, and said potential conflicts of interest among those experts, some of whom had ties to drug companies, were not well managed." Notably, the report warns that "under WHOs health oversight, the world is not ready to handle a major health disaster in the future." The New York Times (3/11, A8, McNeil) reports that a "panel of independent experts has harshly reviewed the World Health Organizations handling of the 2009 epidemic of H1N1 swine flu, though it found no evidence supporting the most outlandish accusation made against the agency: that it exaggerated the alarm to help vaccine companies get rich." The draft report states that the "world is still unprepared to handle a severe pandemic, and if a more dangerous virus emerges, tens of millions would be at risk of dying." The Times adds that although "millions of doses of vaccine ultimately went unused, the panel found no evidence of malfeasance." AFP (3/11) reports that the expert panel states in its draft report that a "key shortcoming at the UN health agency surrounded communication." Notably, the "WHO failed to dispel confusion even in the most basic definition of what constituted a pandemic." The report notes, "One online WHO document described pandemics as causing enormous numbers of deaths and illness, while the official definition of a pandemic was based only on the degree of spread." Reuters (3/10, Nebehay) also covered the story. Researchers Say Pandemic Flu Remains A Public Health Threat. AFP (3/11, Hood) reports that the "H1N1 swine flu that swept the globe in 2009/10 could easily morph into a more transmissible form, while an older, mid-20th century virus could also come roaring back, scientists warned this week in separate studies." The AFP adds that people over 50 today have some immunity to the H2N2 strain called Asian Influenza, which appeared in 1957. But, younger people remain at risk to H2N2. National Institutes of Healths Vaccine Research Center researcher Gary Nobel, who is a "lead author of a commentary published Thursday in Nature," highlights some strategies for predicting a resurgence of the virus. Nobel says, "H2N2 looms as a public health threat, and could re-emerge." The AFP goes on to discuss the two studies Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=133 SMH, Letter to the Editor: Ross Gittins view that the Australian government is paying over the odds for medicines through the Pharmaceutical Benefits Scheme simply doesnt stack up ("Bitter pill when politicians swallow big pharmas spin", March 2). First, the suggestion that brand-name medicines are priced differently on the PBS from generic brands when the patent expires is false. They are priced identically. Second, the article ignores the principal price-cutting mechanism of the PBS that is driving down the cost of off-patent medicines by as much as 70 per cent. These price disclosure cuts are on top of the 16 per cent and 5 per cent price cuts that Gittins does mention. Mandatory price disclosure was introduced last year as part of the Memorandum of Understanding between Medicines Australia and the Commonwealth, precisely to drive savings through a competitive generics market and ensure the sustainability of the PBS. The system forces companies to disclose the discounted price at which they are selling medicines to pharmacies, allowing government to adjust the price it pays to the price the medicine commands in a competitive market place. For example, in the latest round of price disclosure cuts the cost to government of cancer medicine oxaliplatin will fall by 70 per cent. Cuts on other medicines will range between 10 per cent and 45 per cent. These reforms are achieving precisely what they were designed to do: to realise the savings that other countries have been able to drive. Dr Brendan Shaw Chief executive, Medicines Australia, Deakin (ACT Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=132 PLOS Med: Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty. 8 Mar 11. (The authors argue that ethical reviewers and decision-makers pay insufficient attention to threats to validity in pre-clinical studies and consult too narrow a set of evidence. They propose a better way for ethical and scientific decision makers to assess early phase studies. Related discussion: Medical News Today article). Trials Journal: Using a business model approach and marketing techniques for recruitment to clinical trials. 11 Mar 11 (The authors review what is known about interventions to improve recruitment to trials, describe a proposed business approach to trials and discuss the implementation of using a business model, using insights gained from three case studies.) JCRBP: Site Profiles – How to market your clinical research site. Mar 11. (This article discusses the value of collating the professional profile of a clinical research site and provides some ideas on the types of information that might be included.) PLOS One: Dose-Levels and First Signs of Efficacy in Contemporary Oncology Phase 1 Clinical Trials. (A review of 317 recent phase 1 oncology trials (Jan 97 – Jan 09) for first sign of efficacy, maximum tolerated dose (MTD) and their associated dose levels. The authors found the first sign of efficacy was less frequently reported at the early dose-levels and MTD was less frequently reached in trials investigating molecular targeted therapy alone. Similar proportion of trials reported clinical benefit Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=131 RapiSardi IP: On July 21, 2011 the new European legislation on pharmacovigilance will come into force with a view to strengthen EU pharmacovigilance systems including the circulation of information on ADRs and who is responsible for what. A summary of the most significant modifications is provided Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=130 Medical News Today: Banning patents on biological materials will harm Australian patients, destroy Australian jobs and stall medical research, Medicines Australia has submitted to a Senate Committee inquiry into the Patent Amendment (Human Genes and Biological Materials) Bill Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=129 Davies Collison Cave Legal Briefing: A discussion of proposed amendments to the Copyright Act that could have the effect of preventing pharmaceutical companies from commencing legal proceedings for copyright infringement of their TGA approved pharmaceutical Product Information documents Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=128 PharmaTimes: Speaking at last week’s joint BIA/MHRA Personalised Medicine Conference, Sir Gordon Duff, chairman of the UK’s Commission on Human Medicines said there was no clear plan or leadership when it came to personalised medicines and this was particularly seen within the clinical trials landscape. Some of the changes he suggested were required included a need for a more adaptive approach to clinical trials, early authorisation in exchange for post-market commitments and a risk-based approach to regulation Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=127 Australian Academy of Sciences, via AHHA: Changes to the laws governing human stem cell research could put Australian science on the back foot internationally, the Australian Academy of Science has cautioned in its submission to the five-yearly review of the Prohibition of Human Cloning for Reproduction Act 2002 and Research Involving Human Embryos Act Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=126 Pharma Phorum: An interview with Dr Kenneth Kaitin of the Tufts Center for the Study of Drug Development about the current challenges and risks of drug development and how the industry might adapt Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=124 Postmedia news, Canada.com: Researchers from Thomas Jefferson University, Philadelphia have found in a study of diabetic patients treated between 2006 and 2009 by 29 doctors, that increased physicians sympathy and compassion is linked to increased success in treatment of their patients with diabetes Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=125 Science|Business: As the second tranche of projects in the €2 billion Innovative Medicines Initiative was announced this week, a quick stock take of progress to date hints at what this wide-ranging collaboration could deliver Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=123 CRST Media Release: A new survey of over 500 US clinical research site professionals has looked at the impact of trial complexity over the past 3 years and found key challenges in subject recruitment/retention, tracking and reporting data, and trial financials Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=122 Medical Search: Federal Health Minister Nicola Roxon has again defended the governments decision to defer subsidising a group of medicines, even though they were recommended for listing on the medical subsidy scheme Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=121 Media release, AIHW: According to a report released today by the Australian Institute of Health and Welfare (AIHW), Public and private sector medical indemnity claims in Australia 2007-08, just 3% of claims in 2007-08 were settled for $500,000 or more, while almost 70% of the medical indemnity claims involved an amount of less than $10,000, and in 40% of claims no payment was made, nor costs incurred Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=120 MTAA: The Medical Technology Association of Australia (MTAA) responds to the review of the transparency of the TGA. Included are some general remarks, as well as industry specific comments on improving communication, guidance, transparency of decision making and complaint handling, and commitment to funding of transparency initiatives Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=119 The Australian: Four brands of flu vaccine have been banned for young children due to the risk of fits, in new Health Department advice for the start of the flu season. Chief Medical Officer Jim Bishop has stepped up surveillance for side-effects from this years flu jab. In a letter to doctors this week, they have been "asked", although not required, to notify the Australian Childhood Immunisation Register every time they vaccinate a child up to the age of seven years for the flu and "encouraged" doctors to report any side-effects to the TGA Wed, 16 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=118 The Wall Street Journal reports that the Obama Administrations proposed 2012 budget blueprint includes two proposals to speed up availability of generic medications. The first proposal would let the Federal Trade Commission end settlements of drug patent challenges. The second proposal would speed up the availability of generic biologic medications by reducing the market exclusivity of brand biologics from 12 years to seven years. Reuters also covers the story Tue, 08 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=117 Only Abstracts are available free. 3 Mar 11 NEJM: Collaborative Clinical Trials (Perspective article, only first 100 words available free). Related: Press release on EurekAlert: To bring effective therapies to patients quicker, use the team approach 16 Feb 2011 Clinical Pharmacology & Therapeutics: The Value and Benefits of the International Conference on Harmonisation to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health (A discussion of ICH and the expected long-term benefits to global drug regulatory authorities, from the regulators viewpoint. Only abstract available free Tue, 08 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=106 The Guardian (UK): A journalist discusses the movement of staff between EU regulators and companies and a lack of transparency from the European Medicines Agency, including with respect to EudraCT, the EU regulators clinical trial database Tue, 08 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=107 Vic BioPortal: In the next few days, the ABS will commence the first Australian Health Survey (AHS), the biggest health survey ever conducted in Australia. The survey will involve about 50,000 randomly sampled adults and children from across Australia and will give a ‘snapshot’ of Australia’s health. The first wave will be conducted over 2011-12 with results available in late 2012 and will be used by a wide range of health researchers, public health advocates, government, clinicians and community health organisations. Related: Minister for Health and Ageing Media Release: Australian health survey gets underway Tue, 08 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=108 Pharmacy News: The Federal Government’s decision to defer listing seven new medicines and vaccines onto the PBS has been met with an angry response from Medicines Australia. (Only introduction available free Tue, 08 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=109 The Australian: The TGA has ordered drug companies to introduce an "active surveillance" scheme for all new flu vaccines. Hundreds of children will be monitored for fevers and fits from new flu vaccines before they are approved for general use this winter Tue, 08 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=110 The Sydney Morning Herald: Ross Gittins negative viewpoint on the price paid by the government for off-patent pharmaceutical products Tue, 08 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=111 OHMR News: The eighth edition of the Queensland Office of Health and Medical Research (OHMR) eNewsletter has been released with information on funding programs, research ethics and governance, researcher support, intellectual property and commercialisation, events and more Tue, 08 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=112 The blog of the Presidential Commission for the Study of Bioethical Issues: A discussion of the public meeting held in the US today on the ethics around human subjects in clinical trials overseas, and next steps Tue, 08 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=113 Research Australia: The CEOs and Directors of a number of organisations representing Australian industry and research put forward their grave concerns about the unintended consequences of the Patent Amendment Bill introduced into parliament in November 2010 on the access of Australians to life-changing medicines and diagnostics, on the ability of scientists to conduct medical research in this country and on the future of the Australian biotechnology and medicines industry Tue, 08 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=114 PharmaTimes: Discussion from Datamonitor, Medicines Australia and the Generics industry on the expected impacts to the Australian pharmaceutical industry as a result of government changes to the Pharmaceutical Benefits Scheme (PBS Tue, 08 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=115 TGA e-business services - Latest news: Improvements made to the selection and searching capabilities of the ARTG mean consumers, health professionals and industry now have better access to information about medicines and medical devices approved for use in Australia by the Therapeutic Goods Administration (TGA Tue, 08 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=116 TGACC: Updated schedule of 2011 Therapeutic Goods Advertising Code Council advertising seminar to inform and update those involved in the advertising of therapeutic goods on the current requirements for the advertising of therapeutic goods to consumers in Australia - i.e. the application of the relevant legislation and the Therapeutic Goods Advertising Code (TGAC). Compliance with ministerial and default standards: Information intended for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG). Guidance on equivalence of herbal extracts in complementary medicines and Guidance on the use of modified unprocessed herbal materials in Complementary Medicines: two new guidance documents to assist sponsors of medicines that contain herbal substances. Risk management plans for prescription medicines: A Q&A document on Risk Management Plans (RMP) has been uploaded. (An RMP is the set of pharmacovigilance activities and interventions designed to identify, characterise and manage risks relating to a medicine which sponsors of selected prescription medicine products are required to submit to the TGA and periodically update) The TGA is seeking expressions of interest by 4 Apr 11 from people interested in filling positions on the Therapeutic Goods Committee (TGC). TGA Consultation: Required Advisory Statements for Medicine Labels (RASML) Update 6. Interested parties should respond by close of business Friday 1 April Tue, 08 Mar 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=100 The guideline on medicinal products for the treatment of insomnia has been updated A concept paper on the development of medicines to prevent HIV infection has been released for a two-month public consultation period. The concept paper is open for comments until 30 April 2011. Adjusted fees will be coming into effect on Friday 1 April European Medicines Agency launches its geriatric medicines strategy. The first qualification opinion for a clinical biomarker has been released for public consultation. The biomarker is intended to identify patients who can be recruited for clinical trials of treatments for pre-dementia Alzheimers disease Mon, 28 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=99 PLoS ONE 6(2): e14701: An assessment of the completeness of information provided in 731 trials on the International Clinical Trials Registry Platform (ICTRP) database and a discussion of the international moves to improve registry information Mon, 28 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=98 InPharm: The UK government has backed the creation of a free, international online register called PROSPERO to improve the transparency of health research by carrying out systematic reviews for research about health and social care from all around the world, which should in turn lead to an increase in reliable estimates about the effects of interventions Mon, 28 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=97 InPharm: The UK government has revised the research contracting process in a bid to streamline research between pharma and biotech companies, universities and the NHS Mon, 28 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=95 NSW Health: On the 25 Jan, NSW Health released an updated policy directive on insurance and indemnity of clinical trials. Of note, it requires commercial sponsors to provide evidence a policy that contains insurance cover for a minimum amount of AUD20 million for any one occurrence and in the annual aggregate. If a commercial sponsor of a clinical trial is unable or unwilling to meet the insurance requirements of this policy directive, it must provide the public health organisation with its reasons in writing Mon, 28 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=94 Medicines Australia Media Release: Medicines Australia chief executive Dr Brendan Shaw today set out four key policy priorities to arrest the decline in the number of clinical trials conducted in Australia Mon, 28 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=93 TGA: A report of TGAs investigation of a possible safety signal. The TGA, working in collaboration with state health authorities, has undertaken an investigation of a possible association between the use of the rotavirus vaccines Rotarix® (GSK) and RotaTeq® (Merck/CSL) and the occurrence of a rare form of bowel obstruction known as intussusception (IS Mon, 28 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=88 AMA: A discussion of the Medical Journal of Australia’s supplement which focuses on clinical application of research done at the Australian e-Health Research Centre Mon, 28 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=87 The Australian IT: The draft concept of operations for the $467 million personally controlled e-health record contains a "wealth of information" but is not yet ready to be shared with the general public. Consultations are continuing Mon, 28 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=86 Media Release: The Australian Government call for e-health partners, with the request for tenders for a National Change and Adoption Partner and National Infrastructure Partners Mon, 28 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=84 Media Release: Australians suffering from serious and life-threatening illnesses will benefit from 7 new medicines and vaccines being listed on the Pharmaceutical Benefits Scheme (PBS) from 1 April 2011, including patients with a blood disorder that leads to extensive bleeding requiring hospitalisation Mon, 28 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=5 They may not be dressed in white lab coats, but the scientists who attended the educational day and Annual General Meeting of the Association of Regulatory and Clinical Scientists (ARCS; www.arcs.com.au) in Sydney on Thursday (23 Nov. 2006) know they play an important role in developing potentially lifesaving drugs and devices. These scientists also know they can’t do their job properly without ongoing professional development, and this is why their association, ARCS, is so important to them. ARCS, a company limited by guarantee, has historically kept a low profile. However, ARCS is Australia’s oldest and largest association for scientific professionals who bring new drugs and devices to the market. ARCS was founded by scientists for scientists. Thanks to many dedicated volunteers, this association, which has been successfully run by scientists since 1984, now provides ongoing professional education and networking opportunities for more than 2000 members in Australia and New Zealand. What started out as an association for clinical and regulatory scientists has now expanded to serve scientists working in many specialised disciplines including medical information, health economics, medical writing, statistics and auditing. At the AGM, the ARCS President and Chair of the Board, A/Professor Karen Woolley, highlighted that “ARCS’ strong financial position is a credit to the members, management and Board of ARCS, and reflects well on the new strategic plan and corporate governance practices embraced this year.” The CEO of ARCS, Dr Marisa Petersen provided members with a comprehensive summary of the achievements of the Association in the past year. As noted by Dr Petersen “ARCS has broadened its educational offerings in the past year, complementing its current training and seminar program with relevant material sourced both locally and internationally. ARCS is regularly working with government departments and regulators to ensure there is consultation with its members and accessible information and training. ARCS is also adopting a higher profile with industry and government leaders to better position the profession, and to assist its members with skills development in times of increasing skills shortages.” Testament to the dedication that these scientists have for their company, the Board of Directors gave up at least one celebratory champagne to have their first meeting immediately after the AGM. The members elected to serve on the ARCS Board for 2007 are: Ian Adams (GlaxoSmithKline), David Ali (The George Institute), Adrian Bootes (Roche), James Bryden (Abbott), Katrina Campion (GlaxoSmithKline), Sue O’Malley (Medical Intelligence), Andrew Taylor (Roche) and Gillian Waddell (Mulbrae Clinical Strategies). A/Professor Karen Woolley (ProScribe Medical Communications) was elected unopposed to continue to serve as President and Chair of the ARCS Board. The importance of ensuring that ARCS remains an effective and sustainable organisation was reinforced by A/Prof. Woolley. She warned that “without well-educated scientists, who remain up-to-date with the latest regulations, technological advances and ‘best practice’ processes, the development and testing of new drugs and devices in Australia could come to a grinding halt.” The fact that these scientists have access to a successfully run association that is focused on providing ongoing professional development is reassuring…not just for ARCS members perhaps, but for all of us whose future health might depend on one of the new drugs or devices these scientists are working on now Thu, 10 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=35 Recent research conducted amongst our members - and in consultation with senior members in management positions - has identifi ed the need for Certifi cation. Therefore, members of ARCS Australia Ltd are now able to gain recognition for their training and experience through a Certifi cation process. The endorsed system proposed will allow members to be able to gain recognition at three levels: Certified Members – Certification through training and experience (min 1 year). A commitment to Continuing Professional Development and the ARCS Code of Conduct is required. Training may be evidenced through: completion of a series of ARCS Training Courses OR completion of one of the Specialist Certifi cates in Clinical Research offered jointly by ARCS and the University of Melbourne (see page 24) OR by providing evidence of an international accreditation recognised by ARCS. Professional Members – Certified Members with a total of 5 years of relevant experience and who have committed to their Continuing Professional Development and the ARCS Code of Conduct Fellows – Must have a minimum of 10 years of relevant experience, with 5 at senior levels, and be sponsored by other Fellow or the Board. Visit www.arcs.com.au/certification.html for more information Thu, 10 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=49 At the ARCS Board meeting on the 21st January 2010, the first three ARCS Certified Fellows (ACF) in clinical research were approved by the ARCS Board. These individuals are: - Katrina Campion, Senior Clinical Research Manager, (Australia and New Zealand), GSK - Carlo Maccarrone, Head of Clinical Research (Australia and New Zealand), GSK - Dr Sue Mitchell, Principal, Mitchell Clinical Consulting Pty Ltd Congratulations Sue, Katrina and Carlo on being our first Fellows in clinical research within the Association Thu, 10 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=61 The ARCS Australia Board is delighted to announce the appointment of Adrian Bootes as new CEO of ARCS Australia – his first day in the role will be 2nd August 2010. Adrian has been an active ARCS member since 1993, during this time, with the exception of only a few years he has served on and led various committees, including Regulatory, Education, Internet, Corporate Governance and Audit and Risk Management, the latter four during his two periods on the ARCS Board. More than anything Adrian has demonstrated a passion for the organisation as a volunteer and taken on the roles, some unseen, that needed to be done for the membership. Some of the innovations he presided over were the first ever ARCS/TGA/PBB Canberra meeting and Clinical Conferences in Double Bay in the 90s, the first ARCS web site and the first ARCS Risk Management Plan. Adrian brings to ARCS many years of experience as an associate, project manager and line manager in both Clinical and Regulatory areas in a Pharma department with an Asia-Pacific focus, as well as academic training in Pharmacy and Business Administration, and a personal desire to see his team members develop and ARCS succeed. Over the last years, Adrian has concentrated on Audit and Risk Management for ARCS. Judicious spending of the dollars has been good training for his first role in a not-for-profit organisation! With ARCS having put a new strategic plan in place, put clinical certification under its belt and a move back to two major conferences a year, one of which is in Canberra, ARCS will look to continue to engage its existing members with innovative programmes as well as looking at additional groups for professional development as well as the move into Asia. Please join us in welcoming Adrian to this new and exciting role Thu, 10 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=56 This was so great – and it is only the beginning! The “second half” of ARCS Scientific Congress for 2010 is coming up in September and registrations open in July! Read on to reflect on Sydney or to see what you missed! Wednesday 26th May proved to be one of those rare but memorable Sydney days with torrential rain and howling winds. This was the day all the Exhibitors and the Business Office staff needed to set up the Congress, and for me, there was more than a little anxiety about how we would manage if the weather continued – contingency plans were well underway! However, the gods were smiling on ARCS, the rain and wind abated and on Thursday and Friday 630 delegates were able to enjoy the new venue and the high-quality program without hindrance. And my blood pressure returned to normal. 2010 is the first year of a new format for Congress – 2 days in Sydney focused on research and development, and 2 days in Canberra focused on registration, regulation and reimbursement. Splitting Congress means a smaller attendance at each – we were delighted with the numbers in Sydney (60% of the 2009 total) and expect to exceed this in Canberra given interest to date. A smaller delegate numbers means much greater choice of venues and we chose the Australian Jockey Club facilities at Royal Randwick this year – a great choice as it turned out with large, airy rooms with natural light streaming in, views out across the racetrack, plentiful complimentary parking and a fabulous staff who could not do enough for us. Innovation was also strong in the Program Stakes. The Opening Plenary took the form of a debate: That Commercial Interests Threaten the Integrity of the Medical Literature more than Non-Commercial Interests. This serious topic was well developed by both teams and the novel format enabled humour and time honoured debating techniques to be woven into the arguments. The debate was judged by both the audience and a panel of judges, both groups awarding the debate to the Negative Team of Dr Karen Woolley, Dr Russell Basser and Mr Will Delaat on the basis of better use of evidence in their arguments. The Affirmative argument was ably presented by Prof Colin Thomson, Prof Paul Komasaroff and Dr Martin Van Der Weyden but they were unable to sway the judges with their arguments. The debate was both enjoyable and intellectually stimulating for the audience who were treated to a passionate presentation of both arguments. The bar was set at a very high level by the debate, but the ensuing Concurrent Sessions on Day 1 were very well received – creating considerable discussion and enthusiastic exchanges of information by delegates during breaks in the Exhibition Hall. The attendees voted Cindy Hall as Best Speaker on Day 1 – Cindy is a Clinical Research Manager at Princess Alexandra Hospital, Brisbane and she spoke in the session titled: Linking Employee Engagement to Effective Deliverables in Clinical Trials. This was a fascinating topic linking personnel management with the ability to deliver on clinical trial metrics such as recruitment. This session rated well, however the session voted by delegates as the best on Thursday was Conducting Clinical Trials in large Asian Markets – a session submitted by the Asia Pacific ESC and chaired by its (retiring) Convenor, Cheryl Townsend. Congratulations to Cheryl and Cindy who each received a Winners Ribbon (a “racing rosette”) and a Myer Voucher. Friday dawned with sunshine – a good thing after the enthusiastic involvement of delegates in the Conference Dinner activities. There was “betting” on phantom races, Fashions on the Fields, food, wine and dancing late into the night. Friday morning saw the introduction of half-day workshops – 5 sessions all of which were developed and run as highly interactive and effective workshops from 9am until 12.30pm – enabling more in-depth treatment of the topic and practical application of the learnings. Feedback was excellent, and I want to thank all the Workshop leaders and speakers who put a tremendous amount of time into developing these valuable sessions. Deborah Monk, who developed and ran the workshop on the Implementation of the New MA Code of Conduct was voted Best Speaker for Friday, whilst one of the afternoon sessions Perceptions versus Reality in Managing Studies in Asia Pacific was voted as Best Session. This session was submitted by Kendle Australia, and chaired by Ric DeGaris of Kendle. Congratulations to Deborah and Ric who received prizes as noted above. The final session of the Congress was a plenary with a difference! To the pulsing beat of Madonna’s Express Yourself, Dr Joe Badolato from the ARCS Business Office ran a very successful Express Learning session where delegates had the chance to choose from over 20 topics and participate in three 20 minute discussions with subject experts. To help get in the mood for the Closing Drinks, attendees were treated to a wine tasting at each of the change-overs – with wines sponsored by NSW Wine Society. Joe is to be commended on developing and managing this session – another great innovation for ARCS Congress! Whether you were there, or sorry you weren’t……do make sure you talk to your manager about registering for Canberra and/or ensuring budget is available for the 2011 ARCS Congresses. For those who were there – be sure to share your learnings with your manager and thank them for supporting your attendance. Share your new knowledge with your colleagues and make sure you implement those key learnings, making the most of this professional development opportunity. Canberra will be a cracker – how will it rate against Sydney? Time will tell. Don’t miss out Thu, 10 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=60 The TGA has released its new fee scale, along with an accompanying summary and explanatory note. Full information can be found at http://www.tga.gov.au/fees/fees10.htm Thu, 10 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=66 Our small dedicated office has been moving forward with new initiatives and growth in line with the ARCS Strategic Plan. We are putting in place the necessary steps to support the ARCS Asia organization that will be formed shortly. The audit has been completed and our large-scale return to Canberra on track with over 420 registrants so far. There have been some Board changes with Sian Slade and Andrew Taylor both recently moving overseas and us welcoming two new directors Sarahann Simpson and Teresa Schafer to the Board. In addition Katrina Campion, our ARCS President has been selected for short-term volunteer work in Washington D.C., which she is ably managing in addition to her ARCS commitments. Within the ARCS Business Office, Bridget, Penny and Joe continue as dedicated stalwarts of the organization. Belinda King has had a baby boy, Rondo, and is on maternity leave - her role of Education and Events Coordination is being covered by Elizabeth Quinn-Joya. Katy King (Regulatory Affairs Manager) has had a baby boy, Rohnin, and moved to Lismore with her husband. Katy’s maternity leave replacement Theresa Dickson-Bogie continues to deliver the regulatory courses for ARCS. George Azoury has joined us in a Regulatory/HE and Quality project management capacity as the Regulatory Affairs Training Manager. In coming months, Paula Mackie (currently Clinical Research Training Manager) will transition to become the ARCS Clinical Projects Manager, allowing her to pursue her passion for e-learning and education development with ARCS. To replace this role as well as to expand our offerings, we have advertised for an additional headcount in the form of a Medical Education Manager. For those of you who may not have heard, Marisa is enjoying her new role at George Clinical but is not too far away, and remains involved with some key strategic initiatives, and Adrian is settling in nicely. A last bit of news is that we will expand further in 2011 so watch this space! Kind regards, Adrian Bootes and Joe Badolato Thu, 10 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=68 Congratulations to all those involved in organising the very successful Canberra Congress especially the hard work invested by the ARCS team in the Business Office. As board members, we proudly accepted a multitude of positive comments about the programme, the venue and the social events from the delegates and speakers. Most rewarding was the strong registration response from the membership that reinforced the return to Canberra is a valuable addition to the ARCS annual educational programme and a must attend event for those working in Regulatory or Health Outcomes. Katrina Campion ARCS President Thu, 10 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=73 The ARCS Business Office, on behalf of the Board is pleased to announce the results of the elections held at our AGM on 3 November at the Kirribilli Club. Sarahann Simpson, Teresa Schafer, Trevor Schoerie and James Bryden were returned for two year terms. Rosalie Cull kindly accepted the Board’s invitation to join the Board for a one year period, being the position vacated by Adrian Bootes upon accepting a role within the organisation. Please join with the ABO in welcoming these directors to the Board. Katrina Campion, Ailsa Surmann and Amanda Jubb constitute the continuing Board members till Q4 2011. The Board also bestowed life membership upon past-President and recent CEO, Marisa Peterson as well as past Board members Andrew Taylor and Adrian Bootes. Overall it was a very successful day, with over 200 attending the TGA Business Process Reform session as well as the well-attended Management and Leadership Forum, where professional speakers Ms Anne Jewitt, Prof. Richard Badham, Mr Malcolm Dawes and Mr Gary Bertwistle gave excellent insights into the many aspects of Management and Leadership. Their presentations will be posted on the ARCS website shortly. Thank you also to all members who voted, either in person or by submitting a proxy. Kind regards, The ARCS Business Office Thu, 10 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=74 This years Melbourne IAC annual dinner was held Thursday December 5th in Ethiad Stadium, Docklands, Melbourne. The event, sandwiched between the opening and closing nights of U2s 360oC tour allowed the 97 registrants to enjoy drinks on the stadium floor with the bands vast stage as an impressive backdrop. This years speaker was Dr. Linzi Wilson Wilde, General Manager of National Institute of Forensics, Australia. Linzi gave an overview of the institute and kept all the guests on the edge of their seats with firsthand accounts of her (sometimes grizzly) experiences when attending local and international crime scenes. Entertainment on the night was provided by one of Melbournes newest bands "Lounge Elixcir"; who delivered two sets of acoustic favourites ranging from soul and blues to current tunes. The bands lead singer, Martene Bond, is a Melbourne IAC member herself, proving that IAC members are a diverse and multi-talented bunch. A big thank you to all our sponsors on the night and the fabulous spot prizes including wine, champagne , chocolates, and luggage to name but a few. Thank you also to IAC member Annabelle Coomerawel for putting in so much effort in arranging a great night. Regrettably, the dinner represented the last event involving Mary Nteris as a co-convenor of the Melbourne IAC after a three year tenure. If you would like to become a co-convenor please get in contact with the ARCS business office on Thu, 10 Feb 2011 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=59 A working group associated with the NZ Association of Clinical Research is developing a standardized CTRA along the lines of the Agreement developed in Australia. It will include a Schedule 7 and they are currently seeking input on Schedule 7 changes that have previously been requested when using the Medicines Australia templates. The sCTRA Working Group would like to consider adopting any commonly requested changes in the main body of the first draft of the agreement. A review process and timelines will be released at a later date in order for stakeholders and other members of the clinical research industry to submit substantive feedback on the first draft agreement. Please email your Schedule 7 items to be considered by the sCTRA Working Group by close of business Thursday 15 July 2010 to info@nzacres.org.nz with the subject line “sCTRA Working Group” Tue, 27 Jul 2010 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=27 ARCS is delighted to announce the appointment of Insurance House Group as our preferred Professional Indemnity insurance provider for members. Insurance House Group has been established for 25 years, employs 55 staff and is one of Australia’s largest privately own insurance brokers. They are innovative, professional and dedicated to protecting clients. ARCS has reviewed the capabilities of Insurance House Group and is confident they can deliver the insurance solutions members need, with: A dedicated member service team In-depth industry knowledge Tailored policy coverage Access to all insurers Competitive premiums In-house claims teams As a full service insurance broker Insurance House Group can also assist with other member insurance needs, both business and personal. For more information visit: http://www.arcs.com.au/My-Benefits.html Wed, 04 Nov 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=37 NHMRC’s Council has agreed with a recommendation from the Australian Health Ethics Committee that a minor amendment be made to the 2007 National Statement on Ethical Conduct in Human Research. This change affects the chapter on People with a cognitive impairment, an intellectual disability or a mental illness (Chapter 4.5). Details of the change are available on the NHMRC website Wed, 04 Nov 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=29 The NSW Department of Health has updated its policy directive on the use of standard CTRAs. There is no substantive change, except for the inclusion of CRO CTRA. To review the changes, please visit the NSW Health website and scroll down to the section titled Clinical Trial Research Agreement. Visit the website at http://www.health.nsw.gov.au/ethics/research/governance.asp Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=30 NHMRCs Australian Health Ethics Committee has developed a revised Position Statement: Monitoring and Reporting of Safety for Clinical Trials Involving Therapeutic Products. This statement replaces the HREC Alert issued by NHMRC on 18 April 2007 and clarifies the requirements for safety monitoring, reporting and review of clinical trails. The revised Position Statement is available on the NHMRC website. ARCS will be conducting an Evening Update (seminar and webinar) on 27th July 2009 to provide further information. More information to follow Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=26 In these harsh economic times when many businesses and activities are seeing a downturn, the ARCS 18th Annual Scientific Congress defied the odds by attracting 1,168 delegates – a 5% increase on last year’s figures. Run from the 1 – 3 June 2009 at the Sydney Convention and Exhibition Centre, delegates were again treated to an extensive range of scientific sessions – 44 in total (10% increase on 2008) - focused on the latest information and facts on what’s happening in the therapeutic development arena. To coincide with the theme “Education into Practice”, the 2009 Congress introduced daily brainstorming sessions whereby delegates came together to share what they had learned that day and identify three elements they would implement back in the workplace. This concept was well received as it helped reinforce, in both the delegates and their managers, the value of attending the Congress. With the large range of sessions, this year, we were able to attract a vast array of attendees, with the delegation consisting of Team Leaders & Managers (32%), Associates (30%), Senior Associates (15%) and CEO/GM/Director/Senior Management (14%) who were predominately employed in Clinical Research (31%), Regulatory Affairs (30%), Medical Information (8%), Health Economics (6%), and Pharmacovigilance (6%) within the industries of Prescription (52%), CRO (9%), Biotech (8%), Government & Academia (5%), OTC & Complementary (3%) and Devices (2%). So far feedback from delegates has been extremely positive: “Just wanted to write and let you know how much I enjoyed the ASC this year. The topics were relevant, and the sessions were well organised and informative. Thats a great effort as I know how much work goes into the organisation of each session. Congratulations to you and the organising committee!” “A quick note to thank you and the team for an excellent meeting. All the presentations I attended on days 1& 2 were interesting, informative and well delivered - and the opening session on QUM was just terrific! I liked the innovation of getting us to put our key learnings and actions down on paper - focused the mind pretty well!” Although the 2009 Congress has only just finished, planning for 2010 has already begun! Be sure you put your budget requests in now so you too can be one of the 1,000 expected to attend next year Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=32 ARCS is pleased to be associated with the Clinical Trial Magnifier 2009 Conference as a Supporting Organisation. The Conference will be held on November 13-15, 2009 at The University of Hong Kong. We encourage you to provide this information to your affiliate organizations conducting research in the Asia Pacific region. Earlybird and Group Registration discounts apply. Earlybird closes 31st July 2009. Program information and all conference details are available at www.CTMConference.com. Fri, 24 Jul 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=31 Queensland Health (QH) tendered has appointed DLA Phillips Fox to provide legal services across all sites in QH for the review and advice on non standard clinical trial/research agreements. This initiative should assist in streamlining the legal review process and assist Districts in accessing timely and consistent advice and direction on non standard agreements. All the District lawyers have been notified and all requests for contract review are to be sent through the District lawyer, who will initiate contact and request services Fri, 24 Jul 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=6 Yes – its over for another year, but it was a great success! 1052 registered delegates enjoyed the Congress – and in total, 1150 interested parties walked through our doors which included final year and post-grad students interested to know more about opportunities for careers in therapeutics development, visitors to the Exhibition Hall, and of course a large number of members and non-members attending the education sessions. ASC is ARCS flagship event, an event we aim to deliver to International standards (for half the price) and our success was confirmed by several of our international and keynote speakers. 41 sessions – an increase of 20% on 2007 - meant 123 speakers and 41 sessions chairs gave their time to develop sessions which explored new advances in the many facets of therapeutics development (clinical research, Asia Pacific development, quality issues, regulatory affairs, pharmacovigilance, data management and statistics, health economics), the communication of research results and medical information to the broader community, workplace management skills and leadership development Wed, 02 Jul 2008 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=1 The Annual General Meeting of the Association of Regulatory and Clinical Scientists to the Australian Pharmaceutical Industry Ltd (ARCS) yesterday voted to change the name of the Association to ARCS Ltd and to adopt a new Constitution. These moves were designed to reflect the increasingly diverse roles of its 2000+ members - no longer just regulatory affairs and clinical research professionals. These moves also allow ARCS to encompass a broader industry sector - no longer just the pharmaceutical industry, but the much broader ‘therapeutic goods’ sphere. The name ARCS Ltd will be used together with the tag line – Professional Development for the Therapeutics Industry™. The new Constitution also ensures compliance with the Corporations Act 2001 and corporate governance good practice. ARCS is a member-based professional association with a mission to provide high quality education for its members. ARCS provides regular Information Bulletins (covering key updates and industry news), training workshops, a seminar program developed by 11 special interest groups and conferences. The new Constitution reinforces the professional standards expected of its members and provides for a new Class of membership called Overseas Associates. This Class will encourage membership from the various countries with an interest in the Australian research environment and ARCS’ services. The goal of the Association is to be able to meet the needs of this group more effectively in the future through e-learning and the development of co-operative agreements with organisations in their country. This AGM brought to a close two very productive years as President of the Association for Prof Karen Woolley who has focused the Board’s attention on bringing its corporate governance activities into line with good practice. The incoming President, Katrina Campion expressed the thanks of all the membership when applauding Prof Woolley’s wonderfully passionate and energetic leadership for the Association. At the AGM, ARCS’ Professional Development Manager, Dr Joe Badolato, also announced that the ARCS Board will introduce a second scholarship for members, which will support contributions towards original Australian research. This second scholarship is in keeping with the changing nature of the ARCS membership and complements the aims of the Osmond-Russell Memorial Scholarship, which was introduced in 1987 to enable skills development through study or research opportunities. Alongside the AGM, attendees were treated to a full day of professional development sessions, led by a keynote session dedicated to exploring the Medicines Australia Code of Conduct and how it applies to those involved in the development and marketing of therapeutic products. The session, chaired by Deborah Monk (Director, Innovation and Industry Policy at Medicines Australia) examined the important relationship between industry and physicians/researchers. The session speakers challenged the audience to think of how to manage this relationship appropriately in order to maximize the important educational role of industry for the medical profession whilst maintaining public confidence that this relationship is not being exploited for commercial gain. For more information contact: Marisa Petersen, CEO, ARCS, 02 8905 0829, marisapetersen@arcs.com.au Fri, 20 Jun 2008 00:00:00 GMT