http://www.arcs.com.au/newsletterrssfeed.aspx arcs letter feed en-au Late 2009 and early 2010 saw signifi cant changes to not only the temporary Subclass 457 visa regime but also to the General Skilled Migration Program for Australia. The Department of Immigration & Citizenship (“DIAC”) have also foreshadowed further changes expected in July 2010 that will make it increasingly difficult for skilled migrants without specific skills in short supply, or an employer sponsor, to migrate. In this article the new rulesfor the 457 Visa are reviewed and information is provided on the Living Away From Home Allowance and on applications for permanent residency in Australia. To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now Wed, 28 Apr 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=148 http://www.arcs.com.au/ARCS-Newsletter.html Facebook’s popularity is increasing in the commercial sector, with active participation from the pharmaceutical and medical industry. Facebook isn’t just for chatty teenagers anymore. Thousands of companies use the site on a daily basis to drive business objectives. They are using Facebook to engage with their market, to build on-line communities, and to deliver coordinated, branded programmes to their consumers. The result of this is enhanced connectivity and stronger emotional bonds between companies and their followers – being the main objective of any social media and networking initiative. To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now Wed, 28 Apr 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=150 http://www.arcs.com.au/ARCS-Newsletter.html The Medical Technology Association of Australia (MTAA) is the national association representing companies in the medical technology industry. Medical technology companies manufacture and supply a wide range of life-saving and life-enhancing medical products. These products contribute to earlier diagnosis and less invasive intervention; they return patients to productive working lives and assist them to live independently in their own homes. The MTAA Code of Practice (‘the Code’) encourages voluntary, ethical interactions between companies in the medical technology industry and healthcare professionals. It draws a clear distinction between interactions which advance medical technology and those that influence decision-making inappropriately. To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now Wed, 28 Apr 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=151 http://www.arcs.com.au/ARCS-Newsletter.html The modification in regulatory framework for clinical trials has been an ongoing process among regulatory agencies worldwide, including India. As the number of clinical trials conducted in India continues to increase, a number of regulatory changes have been implemented recently in an effort to support these clinical trials and to ensure transparency. The changes were implemented by the Drug Regulatory Authority of India [Drugs Controller General (India) (DCGI)] after a thorough evaluation of the existing regulations and discussions with the number of clinical research organizations (CROs) and other industry experts. Among other areas, the changes include defi ning review timelines, registration of clinical trials and transfer of the approval responsibility for the export of blood, serum and plasma samples from Directorate General of Foreign Trade (DGFT) to the DCGI. The introduction of set timelines for the review of clinical trial applications has streamlined the review process at the DCGI office. To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now Wed, 28 Apr 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=152 http://www.arcs.com.au/ARCS-Newsletter.html As the regulator of prescription medicines, part of the role of the TGA is to facilitate the supply of medicines of an acceptable quality, safety and effi cacy to the Australian public. To do so, the TGA employs a risk management approach. Two recent changes which stem from the TGA’s Business Process Reforms illustrate the TGA’s evolving approach to the regulation of prescription medicines in Australia. This article provides a brief overview of two new measures that affect how the TGA goes about discharging its regulatory functions. Even at this early stage of implementation, it is possible to see a push towards the increased monitoring of the safety of prescription medicines, especially at a post marketing stage. Another emerging challenge is how to best strike a balance between transparency and the protection of commercial know how. To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now Wed, 28 Apr 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=153 http://www.arcs.com.au/ARCS-Newsletter.html The “Introduction to the Electronic Common Technical Document (eCTD)” workshop included presentations by David Plant (CSL Bioplasma), Mark Bailey (Kendle International) and Nick Ward (Pharma To Market). The session was developed by the Regulatory Education Sub-Committee and chaired in Melbourne by Niall Morrissey (Hospira Australia) and in Sydney by Johanna Hann (Pharma To Market). The workshop gave a high-level overview of eCTD, encompassing the fundamentals, eCTD best practices and implementation options. To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now Wed, 28 Apr 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=154 http://www.arcs.com.au/ARCS-Newsletter.html July 1st 2010 will see the introduction of changes to the Good Manufacturing Principles (GMP) for medicinal products. Many companies will be unprepared for these changes and will need to invest signifi cant resources to remain GMP compliant. This article summarises the key changes and how you could be affected. It recommends using a Quality Risk Management approach to identify the changes you need to make and prioritise where to direct your efforts in order to be ready on July 1st. To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now Wed, 28 Apr 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=155 http://www.arcs.com.au/ARCS-Newsletter.html ARCS and the University of the Sunshine Coast (USC) have entered into a partnership to offer a new introductory course in clinical trial management for biomedical science students. The new course will be the fi rst undergraduate training in clinical research offered by ARCS at an Australia university. The goal of this exciting initiative is to provide the USC biomedical science students with an opportunity to develop some of the skills necessary to conduct clinical research to appropriate standards during their undergraduate studies. Opportunities exist for industry for industry to establish scholarships and cadetships for the USC biomedical science students who study the new course and to take advantage of the availability of graduates with core knowledge of the skills required in clinical research positions. To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now Wed, 28 Apr 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=156 http://www.arcs.com.au/ARCS-Newsletter.html It is important for members to know that ARCS is in the process of reviewing its volunteer model – the ways and means by which ARCS’ members contribute to the success of their organisation. The Association is over 25 years old and the landscape both within the organisation, and around it – where its members live and work - has changed considerably. It is time to look hard at our operations, listen to our members and learn from what other similar organisations have implemented. Over the coming months there will be several opportunities for members to tell us how they would like to contribute, how they would like the model to be constructed and what support and recognition they would like to see in place. To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now Wed, 28 Apr 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=157 http://www.arcs.com.au/ARCS-Newsletter.html Well, most of us know that Karen and her husband Mark are running their successful medical communications business ProScribe Medical Communications from a base in Noosa, Queensland. What we don’t always see is that this particular Small, Smart Giant continues to push new boundaries to ensure that her philosophy on small business in Australia is heard. Karen was nothing less than the cover-girl for the March 2010 Profile Magazine. Using Karen’s words, she turned up for the photo shoot in her professional suit – the magazine team looked her up and down, then said “Nice suit – do you mind if we take you to Italia Boutique?” Nerdy scientist plays dress up! To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now Wed, 28 Apr 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=158 http://www.arcs.com.au/ARCS-Newsletter.html ARCS is unique in that it offers a neutral forum for exchange of information to foster the professional development of its members and others contributing to the development of therapeutic goods. To facilitate meaningful and effective dialogue between stakeholders ARCS is holding TWO Congresses in 2010 on Thursday 27 & Friday 28 May in Sydney and Monday 13 and Tuesday 14 September in Canberra and we warmly welcome you to attend one or both! The process of bringing new therapeutic goods to market and to patients is all about partnerships – between industry, discovery groups, researchers and government during the development stages and between industry, regulators and government during registration and reimbursement negotiations. We are delighted to have collaborated closely with the TGA, the PEB and the PBAC, with several government departments at State and Federal level, with research networks across Australia and with peak industry bodies in the development of this program. Make sure you visit www.arcsconferences.com – our dedicated Congress website where all the latest updates and information are being posted. You can see the details of BOTH programs there - both programs will likely hold interest for you – broaden your horizons! Register early and register with colleagues – special Earlybird discounts apply and there are also group discounts for 5 or more registrations to one Congress. To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now Wed, 28 Apr 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=159 http://www.arcs.com.au/ARCS-Newsletter.html In the first 3 months of the program, we have 65 members from the clinical research discipline (which represents 10% of our clinical research members) who have started down the path of certification. The ARCS certification process recognises members’ experience and training at three levels: 1) ARCS Certified Members (ACM) 2) Professional Members and 3) Fellows. Visit www.arcs.com.au/certification.html for more information. To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now Wed, 28 Apr 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=160 http://www.arcs.com.au/ARCS-Newsletter.html In the past year, many of us have been captivated by the ample hype around Twitter, Facebook, LinkedIn and many other social network sites available for almost every imaginable interest. As a member based association we all know the value in coming together as a community to share our own views, information and to network with like minded people. There are many externally hosted social network sites that provide ARCS with an opportunity to establish a presence and to participate on, but how does one decide which is most appropriate and worthwhile investing time in? To answer that question we first need to establish the capabilities of our own ARCS website and to determine our objectives for being in the social networking space. To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now Wed, 28 Apr 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=161 http://www.arcs.com.au/ARCS-Newsletter.html You have noticed some exciting new training programs for both clinical and regulatory professionals. In this article I provide some additional information on the Non-clinical Assessment of New Medicines, the Pharmaceutical Law Workshops and the Essential Documents and Good Documentation Practices (GDP) computer-based training program. To access the full article, please login to the Members Area or if you are not yet an ARCS Member join now Wed, 28 Apr 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=162 http://www.arcs.com.au/ARCS-Newsletter.html In the December 2009 edition of The Source Document we provided an update on the activities of the Pharmaceuticals Industry Council R&D Taskforce or RDTF (report on a seminar held at ARCS Australia on 7th December 2009). Dr Melissa Grady, the Co-Chair of the RDTF spoke of the formation of the Australian Government’s Clinical Trials Action Group. The activities of this group are well underway – the reporting timeframe is very short with the fi nal report due in April Thu, 11 Feb 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=146 http://www.arcs.com.au/ARCS-Newsletter.html The global competition for attracting clinical trials is increasing. For Australia to continue to attract the level of clinical trial activity that it has achieved over the past two decades it is important that strategies are implemented to enhance the clinical trial environment in Australia. For this to be achieved support will be required from different stakeholders including state and federal governments, health departments, hospital bureaucrats, researchers and industry. Receiving this support will be assisted if the value of industry sponsored research is understood. To assist in obtaining this information a survey was conducted on behalf of the Pharmaceuticals Industry Council (PIC) in Australia to assess what value Australia derives from involvement in industry funded clinical research as judged by investigators and study staff. The results of the survey were collated by the NSW Clinical Trials Business Development Centre Thu, 11 Feb 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=145 http://www.arcs.com.au/ARCS-Newsletter.html The Pharmacy Alumni Association at the University of Sydney went from strength to strength during 2009 and is looking forward to another productive year in 2010. The new executive committee, elected in May 2009 at the Association’s Annual General Meeting, is committed to designing programs and activities that will appeal and be of benefi t to alumni of all ages, sectors and backgrounds. Executive Committee members are; Ross Brown, Lillian Chen, Lachlan Rose, David Maxwell, Elie Abdallah, Marisa Petersen and Patti Payne. The Faculty of Pharmacy hosted two very successful reunions for 1949 and 1959 Materia Medica during September and October last year complete with tours of the Faculty labs and new buildings and of course quite a bit of catching up and socialising! Some graduates hadn’t seen each other in 60 years Thu, 11 Feb 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=144 http://www.arcs.com.au/ARCS-Newsletter.html ARCS Australia exists to serve the needs of its members through education, information and networking opportunities. Key to our success is communicating the messages to you, our members, and also to potential members who may benefit from what we offer. In this article you will find tips on how to optimise communications with ARCS to ensue you gain maximum benefit Thu, 11 Feb 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=143 http://www.arcs.com.au/ARCS-Newsletter.html Every day millions of professionals are using Twitter to share ideas with others, gather real-time intelligence and build relationships. I surmised that if millions of people were doing it, something must be making sense to them, so I determined to find out more! This article summarizes my personal introduction to, and views of, Twitter. Throughout 2009 I’d been hearing a lot about Twitter but I didn’t understand it and couldn’t appreciate its value, so I started to investigate it more fully. After reading many books and spending countless hours on the Internet I could see where Twitter was going but still struggled with its value. I compared the process I was going through to that of learning a new language – I persevered Thu, 11 Feb 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=142 http://www.arcs.com.au/ARCS-Newsletter.html What is coaching? Amongst the many thousands of definition I have read and heard the one that interests me most is the one I heard in my Intensive Coach Training, “…An interactive process that helps individuals and organizations to develop more rapidly and produce more satisfying results, hence facilitating positive change by improving thinking”. While I was reading the book on “Coaching: evoking excellence in Others” by James Flaherty, I came across this line which really resonated with me, it read that “…until we reveal to ourselves what we understand human beings to be and what they are capable off, we cannot coach them”. My own experience enables me to understand that coaching is an amalgamation of varied elements, a coach acts like a mentor at times, a trainer and when required behaves like a sports coach. Overall coaching helps in enabling an individual to perform better and achieve more Thu, 11 Feb 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=141 http://www.arcs.com.au/ARCS-Newsletter.html This is a brief review of the two-day course, “Biostatistics and Health Economic Methods for PBAC Submissions”, hosted by ARCS on the 6-7th August 2009, at Pfizer Australia. This course was presented by Simon Eckermann, Professor at the Flinders Centre for Clinical Change and Health Care Research, Flinders University, and member of the Economics Sub- Committee (ESC) of the Pharmaceutical Benefi ts Advisory Committee (PBAC); and Michael Coory, Associate Professor of Health Statistics, University of Queensland, and Medical Epidemiologist at Queensland Health. Day one of the course was followed by two presentations by practicing Biostatisticians, Dr Michael Adena (Director, Statistical Consultancy, Covance Pty Ltd) and Philippa Delahoy (Outcomes Research Statistical Lead, Pfizer Australia). The course was chaired by Giao Tran (Senior Health Economist, Roche Products Pty Ltd) and there were approximately 30 attending professionals from the pharmaceutical industry and consultancy. As not all registration requests could be accommodate, this course has been scheduled again for April Thu, 11 Feb 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=140 http://www.arcs.com.au/ARCS-Newsletter.html There has been a lot of talk, and a lot of preparatory action… finally we are ready to go live with a program for your colleagues in the Asia region! This article brings you up to date with the research and consultation that has been undertaken to understand the needs and create the plans to best meet those needs, and an outline of the implementation plan for ARCS Asia Thu, 11 Feb 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=139 http://www.arcs.com.au/ARCS-Newsletter.html In the last edition of the “Source Document” I outlined the process to become ARCS certified. I am pleased to inform you that at the ARCS Board meeting on the 21st January 2010, the first three ARCS Certifi ed Fellows (ACF) in clinical research were approved by the ARCS Board Thu, 11 Feb 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=138 http://www.arcs.com.au/ARCS-Newsletter.html The Convenors of the ESCs are one of the most important and highly valued group of members working as volunteers for the ARCS Association. Collectively, they act as an Advisory Panel to the Board – providing member input and direction to the Board which is then considered in the strategic planning and implementation processes. Convenors are elected from within the ESC, and for a maximum 3 year term. Often, an ESC will have 2, or possibly more, co-Convenors which facilitates continuity during periods of leave or travel, and also enables new Convenors to be introduced and mentored Thu, 11 Feb 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=137 http://www.arcs.com.au/ARCS-Newsletter.html After the great success of the Evening Update series in 2009, we are pleased to provide you with a preliminary schedule for 2010. Evening updates are intended to appeal to a broad audience and provide updates on important developments, trends and changes in our professional environment. They are not intended to be technically specifi c and not an in-depth training opportunity. They are a great way of staying in touch with what is happening and networking with your colleagues after the event. These evening updates are generally scheduled for Monday’s (typically the last Monday of the Month) at the ARCS Business Office starting at 4pm with networking starting at 5pm. If you are unable to attend, presentations are available to members in the My Information Sources section of the ARCS Member website Thu, 11 Feb 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=136 http://www.arcs.com.au/ARCS-Newsletter.html is an exciting year for ARCS and its members. For the first time since the early 1990’s we are holding two ARCS Scientific Congresses (ASC). Each will be two days in duration – you can choose to attend one or both events. We have engaged several key stakeholder groups to support the theme across the two meetings of “Working in Partnership”. These are the “must attend” events for our members – all the elements of Professional Development are incorporated in these meetings Thu, 11 Feb 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=135 http://www.arcs.com.au/ARCS-Newsletter.html Almost 12 months have past since I reported the results of the research project which looked at the needs and form of an ARCS driven certifi cation process. Different aspects and capabilities essential to supporting this program have been gradually introduced over the last year. We are now ready to start certifying ARCS members in the clinical research area. All the most up-to-date information about this process is located on the ARCS website ---> Certification Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=121 http://www.arcs.com.au/ARCS-Newsletter.html The Pharmaceutical Benefi ts Scheme (PBS) aims to provide access to effective and affordable medicines to consumers, by subsidising medicines listed on the Pharmaceutical Benefits Schedule. According to the Department of Health and Ageing, the cost of the PBS is currently around $7 billion per year1. In view of this level of financial commitment, it is not surprising that the PBS has been undergoing substantial change over the past couple of years. Significant reforms commencing from 1 August 2007 had the primary aim of reducing government spending on reimbursed medicines. To access the full article, please join ARCS at https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=MEMSTEPS Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=131 http://www.arcs.com.au/ARCS-Newsletter.html has been a year of real progress for the Pharmaceutical Council R&D Task Force (PIC-RDTF). Real momentum was gained at the beginning of the year with the release of the Pharmaceutical Industry Strategy Group report, emphasizing the importance of increasing investment in clinical trials in Australia. To access the full article, please join ARCS at https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=MEMSTEPS Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=129 http://www.arcs.com.au/ARCS-Newsletter.html The Biological Imports Program (BIP) of the Australian Quarantine and Inspection Service (AQIS) is responsible for issuing import permits for a range of pharmaceutical and biological materials such as laboratory materials, culture media, micro-organisms and therapeutics. Mr Nathan Jamieson, Senior Veterinary Officer, provided information on the subject of import permits, including substances that require an AQIS permit and common deficiencies in import permit applications. This training seminar was organised by the Regulatory Affairs Education Subcommittee. To access the full article, please join ARCS at https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=MEMSTEPS Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=130 http://www.arcs.com.au/ARCS-Newsletter.html million annual investment in clinical trials in Australia can be protected with immediate, co-ordinated national action - please circulate and discuss this information widely. To access the full article, please join ARCS at https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=MEMSTEPS Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=128 http://www.arcs.com.au/ARCS-Newsletter.html The second Joint Medicines Policy Conference was held on 25-56 November 2008 in Canberra. The conference attracted over 350 delegates, a 20% increase over the fi rst conference in 2006. Conference attendees included representatives from the various industry sectors, government departments, PBAC, consumer groups, pharmacists, medical practitioners, medical researchers, the media and international visitors. These conferences are pivotal in achieving a mutual understanding of the varying perspectives on how public subsidy of medicines best operates in Australia, with a particular emphasis on the assessment of medicines through the Pharmaceutical Benefi ts Advisory Committee (PBAC). At the conference nine key outcomes were identified and addressed. To access the full article, please join ARCS at https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=MEMSTEPS Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=127 http://www.arcs.com.au/ARCS-Newsletter.html This article briefly summarises the procedures governing clinical trials in Japan, and progress that has been made in shortening the development process. To access the full article, please join ARCS at https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=MEMSTEPS Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=126 http://www.arcs.com.au/ARCS-Newsletter.html The Code is an essential platform from which the pharmaceutical industry articulates and promulgates an ethical culture through commitment to self-regulation. The Medicines Australia Board recognises the importance of ethical conduct of members by including it as one of the five key pillars of Medicines Australia’s Strategic Plan. To access the full article, please join ARCS at https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=MEMSTEPS Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=125 http://www.arcs.com.au/ARCS-Newsletter.html The ARCS Management Forum is an annual event with a strong focus on management and leadership issues. The second forum, held on 22nd October 2009 was again very well received by attendees. The program was led by an excellent keynote speaker, Prof Danny Samson from the School of Management at Melbourne University, who was followed by the Chairmen of Medicines Australia and the Australian Self-Medication Industry (ASMI) and the CEOs of AusBiotech and the Generic Medicines Industry Association (GMIA) in a session devoted to industry issues and action plans. Both these sessions focussed on leadership – at a company and an industry level. To access the full article, please join ARCS at https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=MEMSTEPS Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=122 http://www.arcs.com.au/ARCS-Newsletter.html The Melbourne ESC annual dinner is a much coveted event that is enjoyed by all who attend, and this year’s dinner was no exception. Over 110 people attended the event which was held at The Point in Albert Park. The venue set the backdrop for a fun evening with delectable food, wine and one of the best views in Melbourne! To access the full article, please join ARCS at https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=MEMSTEPS Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=120 http://www.arcs.com.au/ARCS-Newsletter.html In this second installment showcasing the critical role Educational Subcommittees (ESCs) have within the Association, we take a closer look at the Melbourne, Brisbane, Asia Pacific, Pharmacovigilance, Medical Information and Medical Writing ESC. To access the full article, please join ARCS at https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=MEMSTEPS Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=119 http://www.arcs.com.au/ARCS-Newsletter.html With the tinsel, lights, Christmas trees and Santas everywhere, 2009 is drawing to a close. Congratulations and thank you to Marisa and all the ABO staff, all the ESC convenors and members and everyone else that has generously volunteered their time and experience to support ARCS over the last year. It is through the energy and enthusiasm of volunteers that this much treasured organisation continues to maintain its relevance to members. THANK YOU! To access the full article, please join ARCS at https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=MEMSTEPS Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=118 http://www.arcs.com.au/ARCS-Newsletter.html For ARCS, this is becoming much more of a focus than previously – BECAUSE – these are issues which directly impact our members. Whilst we are not an industry association and we do not lobby on behalf of any sector to government, it is very important that we represent our members in the best ways we can on the relevant cross-functional taskforces which aim to keep and grow research and development of therapeutic goods in Australia. In addition to representing our members, involvement in these working groups enables us to keep our members aware of the changing landscape and the solutions being put in place and facilitate communication and consultation across the breadth of our membership. To access the full article, please join ARCS at https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=MEMSTEPS Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=117 http://www.arcs.com.au/ARCS-Newsletter.html At this year’s ARCS Management Forum there was a very interesting session delivered by Jim Hughes from the PMPartners group which had its genesis from a simple question “Are there some common characteristic to successful project?” We all know the statistics - industry research shows that a third of all projects are delivered late. To add to this, even more come in over budget or run past the original deadline, 28% fail altogether. The aims of the session were to provide: (1) The context and key enablers of successful projects in the therapeutic goods industry and (2) Share some strategies to start the right conversations with the right people in the organisation To access the full article, please join ARCS at https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=MEMSTEPS Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=123 http://www.arcs.com.au/ARCS-Newsletter.html You’ve just been promoted to Project/Team Leader and now you are managing a group of people. Your previous colleagues report to you and the dynamics have just changed. They treat you differently, they want different things from you, so how do you respond? To access the full article, please join ARCS at https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=MEMSTEPS Mon, 11 Jan 2010 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=124 http://www.arcs.com.au/ARCS-Newsletter.html The session on biotech manufacturing process changes and their regulatory implications included presentations by Les Tillack (Pharmasynth Pty Ltd), Dr. Chong Loh (Office of Laboratories and Scientific Services, Therapeutic Goods Administration) and Penny Field (Bioregulatory Consulting). It was developed by the Regulatory Education Sub Committee and was chaired by Liz Joshi (Regulatory Affairs Project Manager, Bayer Australia Ltd). The session introduced common manufacturing processes and changes, regulatory requirements and concepts applied through a working example. Three distinct perspectives were represented; the manufacturer, the TGA and the sponsor Wed, 09 Dec 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=116 http://www.arcs.com.au/ARCS-Newsletter.html Dr. Brian Creese from Kendle Pty Ltd chaired a fact-packed session covering the regulatory and practical considerations of taking the step from nonclinical to first-in-human (FIH) studies. The use of a case study (ARCS09) was very effective in demonstrating how to take theory to a real life setting Wed, 09 Dec 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=115 http://www.arcs.com.au/ARCS-Newsletter.html Pretium Pty Ltd, a health technology assessment company based in Sydney kindly provided three delegates to present on hospital costing data and its application to PBAC submissions. The first speaker was Leanne Stokes, Health Information Manager, who introduced the hospital classification system in Australia. Secondly Dr Munro Neville, Director of Pretium, talked about the concepts of hospital costing and lastly Annette Kerr, Senior Consultant, covered the application of costing studies in PBAC submissions Wed, 09 Dec 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=114 http://www.arcs.com.au/ARCS-Newsletter.html You could almost forgive any Australian who started chanting ‘Aussie, Aussie, Aussie – Oi, Oi, Oi’ during the formal President-elect announcement made during the DIA’s Annual Meeting in San Diego (June 21-25, 2009). For the fi rst time in the 45-year history of the DIA, a non-American reached the status of President-elect. As the DIA has 20,000+ members in 80 countries, the announcement that Australia’s Professor Ric Day would serve as its President from June 2010-2011 was quite the announcement indeed Wed, 09 Dec 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=113 http://www.arcs.com.au/ARCS-Newsletter.html The Therapeutic Goods Administration’s (TGA) Offi ce of Prescription Medicines (OPM) has four initiatives as part of their Business Process Reform (BPR) project which are addressed in this email Wed, 09 Dec 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=112 http://www.arcs.com.au/ARCS-Newsletter.html This article considers some of the triggers for the current focus and selected reform proposals. Governmentled consideration is currently being given to whether a single Code should apply to medical devices and technology, pharmaceuticals (including generics) and complementary medicines. Whilst it is early days, many stakeholders have expressed concerns that a single code approach would be impractical Wed, 09 Dec 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=111 http://www.arcs.com.au/ARCS-Newsletter.html This year saw one of the strongest fi elds of applicants for both the Osmond- Russell Scholarship and the ARCS Original Research Scholarship seen in years with both Scholarships being awarded. At this year’s AGM, Sam Dowdle, Pharmacovigilance Offi cer, Apotex Australia was awarded the 2009 Osmond- Russell Scholarship. Sam’s educational activity is to attend the joint EMEA and DIA ‘Excellence in Pharmacovigilance’ course held in Paris in February 2010. At this years AGM it was announced that this Scholarship was awarded to Serina Stretton, Senior Medical Writer, ProScribe Medical Communication for her project titled “Publication Misconduct and Plagiarism: Who, Where, and How Often”. The primary objective of the research is to determine whether plagiarism occurs more often in developing countries rather than in developed countries Wed, 09 Dec 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=110 http://www.arcs.com.au/ARCS-Newsletter.html Over the next two editions of “The Source Document”, we will be showcasing the critical role educational subcommittees (ESCs) have within the Association. They are the life blood of a professional development association like ARCS - and as members we can all get involved with their activities. This month we will be taking a closer look at the Health Economics, Clinical Research and Regulatory Affairs ESCs. I should take a step back for those new to ARCS, and stop and explain the role of ESCs. An ESC is a group of ARCS members who share a common interest. This may be relevant to their positions in industry or it may be particular to their geographic location. Members meet to discuss issues relevant to them and organise professional development opportunities for members in the Interest Areas. The experience levels within an ESC are variable from the most inexperienced to their managers. This variety of backgrounds helps to ensure mixed approaches to problems. ESC members are volunteers - the voluntary contribution of time to these committees is fundamental to the success of ARCS. Sounds like more work I hear you say!!! But what I hear time and time again is that ESC members get a lot back both personally and professionally from their participation Wed, 09 Dec 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=109 http://www.arcs.com.au/ARCS-Newsletter.html ARCS members have much to gain from being a community, and an open community at that. We do not restrict membership to those with certain qualifications or licences – we exist to enable the growth of all those with an interest in therapeutic goods development. ARCS provides the means for professional development but relies upon the community of members to drive direction, engage with others in the community and take responsibility for their own professional development. ARCS has a small group of members who contribute very strongly – and a vast majority who wait for the benefi ts to be delivered to them! I challenge you to consider whether this is appropriate – ALL members will benefit from majority involvement – sharing problems, sharing solutions, contributing resources, developing their own skills and those of their colleagues and staff. And as a member organisation, this is each member’s responsibility – not that of their employer! So, I challenge you to ENGAGE – take responsibility for remaining aware of your professional world and taking charge of your own professional development and that of your staff and colleagues. Improve your own working space, and contribute to a strong and sustainable future for therapeutics development in Australia Wed, 09 Dec 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=107 http://www.arcs.com.au/ARCS-Newsletter.html The ARCS business has navigated through the doom and gloom of the global fi nancial crisis. The ABO along with the involvement of many Education Subcommittees (ESC), have continued to provide educational and social events including another successful Annual Scientific Congress. New technology has enabled ARCS to reach members and non-members in many ways. Now you may find yourself interacting in an ARCS environment via a webcast of an interactive seminar, through an eLearning module, networking aided by ARCS linked-in community, attending a face to face event, actively contributing to an ESC or spending 15-20minutes providing feedback to the ABO or ARCS Board members via a member call Wed, 09 Dec 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=108 http://www.arcs.com.au/ARCS-Newsletter.html Like all businesses, ARCS needs to continually evolve to remain relevant to its members. Whilst our core business remains the same – to provide professional development services (education, information and networking opportunities) to those working in therapeutics development, HOW we do this must evolve to meet the changing demands of the environment in which we work. There are several key developments for the coming year including: Services in Asia Pacific; On-line Learning; Professional Certification; and Two Major Conferences in Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=95 http://www.arcs.com.au/ARCS-Newsletter.html This is a brief review of the Process Analytical Technology seminar hosted by the Regulatory Education Sub-committee in Sydney, and broadcast as a Webinar, on 17 February 2009. It has been suggested that the manufacture of the popular snack, the potato chip, is more precisely controlled than the manufacture of a life saving medicine. The quality of the chip is checked constantly throughout their manufacture, with constant adjustments made to ensure the same high quality chip arrives at the end of the production line each time. This constant checking is permissible because of Process Analytical Technology (PAT Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=106 http://www.arcs.com.au/ARCS-Newsletter.html The implications of the proposed cost recovery measure for PBS and NIP listings are significant and far reaching. Government has justified the policy as an extension of the existing cost recovery arrangements set for the regulatory (TGA) evaluation process. However, many have opposed the legislation, citing examples where such a policy has the potential to result in poor quality use of medicines Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=105 http://www.arcs.com.au/ARCS-Newsletter.html India stands with a huge population base of more than a billion which is more than 17.5% of the world population[1]. This population base is increasing the need of health care facilities. It is estimated that India has over 700,000 speciality hospitals with more than 200 Medical colleges. India serves as a rich source for not only the skilled English speaking Medical professional but also a large pool of patients suffering from Diabetes, Cancer and other maladies Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=104 http://www.arcs.com.au/ARCS-Newsletter.html The opening plenary on day 2, which turned out to be one of the largest with over 400 delegates, was organised by the TGA and chaired by Charles Maskell- Knight, Acting National Manager of the TGA. ARCS would like to take this opportunity to sincerely thank the TGA for their significant contribution to this year’s ASC and in particular for organising this session. Summaries of reforms and projects underway from the heads of five departments within the TGA were provided Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=103 http://www.arcs.com.au/ARCS-Newsletter.html This article provides an overview of a presentation on ‘Marketing’ that was addressed during a well-attended session at the June Congress. In our current economic environment – both globally and locally it is more important than even for companies to manage their resources carefully. One area of cost containment that requires companies to actually spend money upfront with clinical trials so as to achieve ultimate long-term savings and study goals is early proactive investment in patient recruitment and retention. Workload at the clinical site has increased signifi cantly and today’s study staff are often overworked and burdened with multiple study responsibilities. Recruiting suffi cient study participants and keeping your study top of mind remains a key challenge. Patient recruitment is a challenge that companies must overcome, and it is imperative that it is done proactively. Outsourcing may be viable. Companies that specialise in recruitment and retention can work with project managers or CRAs to implement effective recruitment campaigns and also work with the individual study coordinators to keep participants motivated and supported to ensure that the recruitment efforts are not lost. A marketing plan is crucial to the study’s success. An effective marketing plan provides the blueprint for the study’s success. Furthermore this approach provides the necessary support and enables study coordinators to focus their time on patients in the study Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=102 http://www.arcs.com.au/ARCS-Newsletter.html The Australian Drug Evaluation Committee (ADEC), although not a decision-making authority, has an important role in the approval of new prescription medicines in Australia. It is an independent, advisory body, with diverse expertise in clinical medicine and other aspects of drug development. Dr Geoffrey Herkes, Chair of the ADEC, provided detailed insights into the workings of the Committee, while the other speakers presented industry and TGA perspectives respectively. Potential changes to ADEC procedures to improve effi ciency and to increase transparency were also discussed Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=101 http://www.arcs.com.au/ARCS-Newsletter.html We are witnessing a global shift. Clinical trials are moving to large multi-site projects involving numerous institutions at different locations. In today’s global and changing environment, how do we stay competitive and grow clinical trials, with other countries adopting streamlined approaches to ethics review of multi-site research? How do we improve timeliness, efficiency and provide new treatments to patients sooner, while still maintaining the quality of ethical review and patient safety which Australia, including Victoria, is recognised for? After much consultation, deliberation and planning, Victoria is introducing single ethical review of multi-site clinical trials this year Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=100 http://www.arcs.com.au/ARCS-Newsletter.html Throughout the life cycle of a pharmaceutical product, much documentation is produced relating to the product to support, among other things, its quality, safety and effi cacy, and its promotion and supply. Because of the sheer quantity of information produced, a clearly defi ned document retention policy is essential from a corporate governance perspective, to ensure that the minimum statutory and regulatory requirements are met to minimise the exposure of the company and its employees to possible offences, and to reduce the risk of adverse rulings in current and future litigation involving the company. A summary of information presented at the ARCS Evening Update, March Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=99 http://www.arcs.com.au/ARCS-Newsletter.html Each year ARCS offers two scholarships to Full Members of the Association. The scholarships are designed to enable Members to undertake a project relevant to their work and to other ARCS members – this may be a professional development project or an original research project. Each scholarship is awarded up to the value of $10,000. So, if you would like the opportunity to undertake a research project, expand your own knowledge, raise your profi le within ARCS and help to increase the knowledge of other ARCS members – please apply Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=98 http://www.arcs.com.au/ARCS-Newsletter.html For the ARCS Board and ARCS Business Office, it is time to prepare for the review the financial year just past, focus on defining the goals and objectives for the organisation for the coming 12 months and ensure that we are on target to achieve the three year strategic plan we set for the organisation. Over the coming newsletters and at the Annual General Meeting to be held in October we will provide you with information on ARCS performance in 2008/9 and planned achievements for 2010. It is also the time of year for ARCS full members to consider nominating for a position on the Board! Four of the current board members will stand down and may renominate along with any of you. Are you interested Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=97 http://www.arcs.com.au/ARCS-Newsletter.html In June 2009 the TGA conducted an online survey seeking feedback about its communication and consultation processes, 1618 responses were received. The TGA is currently analysing the responses and expects to provide information on this analysis in the near future. The TGA is very pleased with the number of responses and would like to thank all ARCS members who took the time to complete the survey Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=96 http://www.arcs.com.au/ARCS-Newsletter.html The results of laboratory tests are affected by the collection and handling of the specimen, the particular laboratory and the method of analysis. They are also affected by variability within the individual and within the laboratory. Interpretation at one point in time should consider the position of the measurement within the laboratory reference range appropriate for the sample and the person being tested. Interpreting results over time should consider the likely variability of the measurement and the level of certainty required to identify a true change or absence of change. The more variable the measurement and the higher the required level of certainty, the larger the change between measurements needs to be before it can be considered clinically significant. ‘Reprinted with permission from Australian Prescriber (Aust Prescr 2009;32:43-6)’.   Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=93 http://www.arcs.com.au/ARCS-Newsletter.html Redundancy. You never think that it may happen to you, and when it does, what do you do? There are so many questions, thoughts, fears, and explanations to make. Positions being made redundant are more common than most people think. And certainly the pharmaceutical and healthcare sector is not immune. Jobs are not for life, and business needs change, sometimes dramatically so. Changing business needs sometimes necessitates the employer restructuring the organisation. A position then becomes redundant if the business no longer requires the duties of that position to be performed. The position may also be redundant when it needs to be broken up into several roles and the duties distributed to other positions, when the duties are substantially and fundamentally changed; or there is a major move in the location of the position Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=92 http://www.arcs.com.au/ARCS-Newsletter.html It is such a delight to report to our members on the outstanding success of ARCS Annual Congress in 2009. This was ARCS’ 18th Annual Scientific Congress and also our 25th birthday (see below for photos of the birthday bash!). We all know that the last 9 months have seen major upheavals not only in the global economy, but also in the local R&D environment and both these factors affect the environment in which our members work. So to increase the number of delegates by 5% over 2008 was an outstanding achievement! This year we registered 1,168 delegates who were treated to 44 sessions devoted to 11 different areas of expertise that make up “therapeutic goods development”. Delegates were employed in employed in Clinical Research (31%), Regulatory Affairs (30%), Medical Information (8%), Health Economics (6%), and Pharmacovigilance (6%) and came from diverse segments of the market - Prescription Medicines (52%), CRO (9%), Biotech (8%), Government & Academia (5%), OTC & Complementary (3%) and Devices Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=91 http://www.arcs.com.au/ARCS-Newsletter.html On Tuesday, May 12th the Faculty of Pharmacy and the Pharmacy Alumni Association of the University of Sydney hosted their Inaugural Public Symposium entitled “Pharmacy and the Australian Healthcare Sector: A Key Player or a Silent Partner?” Consultant Clinical Pharmacist Debbie Rigby joined the Faculty’s Pro- Dean, Professor Jo-anne Brien, and Alphapharm CEO John Montgomery to share their candid views on the future of the pharmacy profession. Representing the perspectives of pharmacists in the community, hospitals and industry the panel discussed the role of pharmacists within the healthcare sector with Professor of Pharmacy, Aged Care, Andrew McLachlan acting as moderator Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=90 http://www.arcs.com.au/ARCS-Newsletter.html The opening plenary of ARCS 18th Annual Scientific Congress brought together key speakers on a central theme of the medical and pharmaceutical industry, Quality Use of Medicines (QUM). Professor Ric Day (Professor of Clinical Pharmacology, St Vincent’s Hospital, Sydney, Australia) set the scene by opening with results of a survey conducted prior to the session. Of the responders approximately 40% believed they had either a working knowledge or were very familiar with the National Medicine Policy (NMP) and Quality Use of Medicines (QUM). In addition, around 65% believed the NMP and QUM strategy definitely or possibly increased the public standing and understanding of the Pharmaceutical sector Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=89 http://www.arcs.com.au/ARCS-Newsletter.html As part of its membership support goals, ARCS is developing partnerships which aim to provide members with additional benefits. In response to requests from our members who are consultants in the many facets of therapeutic goods development ARCS has sought to partner with an insurance group with an understanding of what our members do, and a track record in providing professional indemnity insurance for members. Understanding the rather diverse nature of consultants’ roles is critical – if the insurer doesn’t understand what they are insuring they will either make it very difficult or very expensive or simply not be interested. ARCS is pleased to announce that we have appointed Insurance House Group to assist our members with insurance needs. They have already assisted several members to place insurance. They are working with ARCS to develop tailored Insurance Proposal Forms which will assist members as they work through the process, and are available for consultation. As part of this partnership, Gina Villani and Anthony Di Fiore from Insurance House delivered seminars in both Melbourne and Sydney for ARCS members. The Sydney seminar was also available via webinar, and in total more than 50 members attended. The presentation from these seminars is available on the ARCS website under My Information Sources/Evening Updates in the Members’ Area. Below is a guide to Professional Indemnity insurance – what you need to know and what the terminology means Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=88 http://www.arcs.com.au/ARCS-Newsletter.html The 4th Pharmaceuticals Industry Council (PIC) R&D Taskforce (RDTF) Forum was held in Sydney on 25th and 26th March 2009. It was attended by approximately 150 delegates and the focus was on addressing the challenging obstacles to ensuring Australia remains an attractive environment in which to conduct successful clinical trials. The Forum was jointly sponsored by PIC and the Department of Innovation, Industry Science and Research, with logistic support provided by ARCS. This article reports on some of the key presentations and initiative discussed at the Forum. Offi cial Reports from the Forum and the previous Forums, supporting materials and research proposals and papers developed by the R&D Taskforce, can be found at: http://www.pharmacouncil.com.au/resources.php.   Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=87 http://www.arcs.com.au/ARCS-Newsletter.html With the lingering economic downturn and uncertain markets, it is more important than ever to renew your ARCS membership and maintain your alliance with your professional development association. ARCS is dedicated to providing the latest and most up-to-date professional development opportunities for its members and the broader therapeutics development arena. These take the form of training course, seminars, live webinars, conferences with the regulators of TGA and PEB, eBulletins and The Source Document - both compiled to include the latest industry news and developments - and access to a dedicated members only area of the website where you can communicate with like minded professionals and share your experiences and knowledge. For 2009/10, the membership fees are only rising by 3% to $175 (full members). This means with a 40% tax deduction, the cost of membership is just $2.00 per week - less then a cup of coffee. This is a small amount to pay for all the benefits you receive which include Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=86 http://www.arcs.com.au/ARCS-Newsletter.html Marianne Hundling, Clinical Trials Program Manager at the Peter MacCallum Cancer Centre has been working with us for some months to develop a plan for an ESC to support study co-ordinators and other research staff working on a range of clinical research programs. Marianne has agreed to convene this group. ARCS strongly supports this initiative as research conducted by sponsor companies and within institutions have the same goal in mind – to improve patient care by researching alternatives and outcomes – and both need to work to the same ethical and regulatory standards Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=85 http://www.arcs.com.au/ARCS-Newsletter.html With the successful completion of our arrangement with DIA, ARCS will now be offering Project Management and Biostatistics courses through local partners. The ARCS Business Office has been reviewing customer feedback to ensure that the replacement courses will be “bigger and better” at meeting the needs of our members and we are confident that the “new kids on the block” will build on the initial successes and take our educational offerings in these areas to a new level. In this article I outline some of the new and exciting partnerships to look out for in education Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=84 http://www.arcs.com.au/ARCS-Newsletter.html CONGRATULATIONS to the staff in the ARCS Business Office (ABO) and to the Education Subcommittee Convenors (ESC) for a very successful Congress. Many other members also volunteer large amounts of their time to prepare presentations or to find and brief topic experts to lead sessions or find new and dynamic ways to present material to our members. Thank you to everyone who gave of their time, energy and passion to ensure the ARCS ASC 2009 was a great success Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=83 http://www.arcs.com.au/ARCS-Newsletter.html WERE YOU AT THE ARCS 18TH ANNUAL SCIENTIFIC CONGRESS AND 25TH BIRTHDAY CELEBRATION? 1080 delegates, speakers and exhibitors certainly were, and their feedback says they thought it was GREAT! A great program, great sessions, great venue, a great exhibition and great networking opportunities. They have taken away not only new ideas, but action plans to implement them in the workplace. We are delighted with the impact that our theme “Education into Practice” had on this Congress. Speakers and Chairs were focussed on developing sessions with practical application, and every day delegates were coached through the practice of distilling out the key actions they needed to implement in order to transfer their new knowledge into their workplace Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=82 http://www.arcs.com.au/ARCS-Newsletter.html On the 22nd Aug, an industry meeting instigated by Deborah Monk, Medicines Australia, was hosted by ARCS to discuss the current standard CTRA and CRO CTRA in development. Deborah Monk, Bill Karanatsios (VMIA), Arthur Rallis (Phillips Fox Lawyers) and Naho Yamazaki (NSW DoH) were all in attendance to help answer questions about the standard and CRO CTRA’s, as well as to better understand the areas of concern. It was a highly interactive meeting, and this article serves to summarise the various points of discussion and questions raised, in a Q&A format Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=69 http://www.arcs.com.au/ARCS-Newsletter.html In the last edition of this newsletter, we reported on the introduction of the National Health Amendment (Pharmaceutical and Other Benefits - Cost Recovery) Bill 2008 (Cth) (“Bill”). The objective of the Bill was to provide the government with the statutory power to recover fees from pharmaceutical companies that apply for the listing of new drugs, or changes to existing listings, on the Pharmaceutical Benefits Scheme (“PBS”) or designation of vaccines for the National Immunisation Program (“NIP”). However, the Bill was rejected by the Senate in August 2008, following a Senate Inquiry by the Senate Community Affairs Committee (“the Committee”), which considered the impact of the proposed arrangements. In this edition, we report on the Senate Inquiry which led to the rejection of the Bill, and consider the likelihood that fees may still be introduced some time in the future Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=79 http://www.arcs.com.au/ARCS-Newsletter.html ARCS has four Regional Network Groups – or are they really Education Subcommittees? Are there really five??? A difficult line to draw but read on… ARCS has groups of members in Melbourne, Brisbane, Adelaide and Perth and also in New Zealand. The New Zealand members receive a discounted “e-membership” of ARCS if they are members of New Zealand Association of Clinical Research (NZACRes), and conduct their activities effectively under that banner. In a small market with a well organised local group, this partnership works well Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=78 http://www.arcs.com.au/ARCS-Newsletter.html Lisa Ann Dowton sadly passed away on 30th July 2008, having lost her 2 year battle with cancer. Ironically Lisa spent many years managing oncology studies during her years at Lilly Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=77 http://www.arcs.com.au/ARCS-Newsletter.html Summary and highlights of the NZACRes Conference 2008 titled “Clinical Research in Practice” held at Langham Hotel on the 28th and 29th of August 2008. This annual event was attended by 266 delegates in the NZ research industry who came together to share information, further their knowledge and promote networking, all of which fostered the understanding and growth of our research industry Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=76 http://www.arcs.com.au/ARCS-Newsletter.html The ARCS Regulatory Affairs ESC put together an excellent useful insight into Alternative Routes to Registration. Doug Kentwell, Managing Director of Regulatory Solutions, kicked off this session with an overview of the extraordinary applications that regulatory affairs professionals may encounter during their working life Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=75 http://www.arcs.com.au/ARCS-Newsletter.html Health Economic modelling is a tool used to assist decision makers to choose an intervention option that maximises utility to an individual, society, or to a particular community. It is particularly useful in today’s environment where there is uncertainty and limited clinical trial data, yet still the need to make forecasts, evaluations and decisions regarding the allocation of scarce resources. A range of economic modelling techniques were presented, each having its own unique application Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=74 http://www.arcs.com.au/ARCS-Newsletter.html The concurrent session, “Regulation, A Continuum of Care” provided an educating and stimulating forum to learn and understand both the processes involved in the regulatory framework used to assess products in the complementary and alternative medicine arena and also the challenges that face the regulators, the self-medication industry and consumers in today’s changing healthcare environment. This was a fascinating session in which presentations by a number of key stakeholders involved and affected by regulation, provided a clear and insightful picture into the current situation relating to regulation of complementary medicines in Australia Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=73 http://www.arcs.com.au/ARCS-Newsletter.html The Melbourne ESC Social Event was a great success with a wonderful presentation from Geoff Kelly of “Kelly Strategic Influence” on “Infl uence and the Leadership Mindset”. This event was held on the 17th of September 2008 at the O’Meara’s Elgin Inn, Hawthorn and was attended by 31 enthusiastic ARCS members Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=72 http://www.arcs.com.au/ARCS-Newsletter.html The 3rd Pharmaceuticals Industry Council (PIC) Research &Development Taskforce (RDTF) Forum – “Clinical R&D in Australia: Innovation and Global Competitiveness” was held in Sydney on 2-3 April 2008. The Forum was sponsored by the Australian Department of Innovation, Industry, Science and Research (DIISR) and meeting logistics supplied by ARCS. The PIC is a peak industry body with membership and support from AusBiotech, Generic Medicines Industry Association and Medicines Australia. The goal of the PIC is to ensure the growth and development of Australia’s pharmaceuticals industry. DIISR is also represented on PIC. The full Forum report and all presentations are available on www.pharmacouncil.com.au on the “Resources” tab. This focus of this second report is on a number of key initiatives being pursued by PIC RDTF with other stakeholders to further improve Australia’s global competitiveness Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=71 http://www.arcs.com.au/ARCS-Newsletter.html Finding patients for clinical trials almost always begins with a review of available patient databases and anticipated referrals from physicians. Most investigators tend to rely on their study coordinators to screen appropriate patients to determine if they meet the study inclusion criteria. This article reviews some of the advantages that are achieved by outsourced screening so that only qualified study prospects are sent to the research sites Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=70 http://www.arcs.com.au/ARCS-Newsletter.html ARCS has successfully piloted a new model for educational opportunities for ARCS members! Driven by the Health Economics Education SubCommittee, a three day training workshop in Bayesian Statistics, featuring two international experts from Sheffield University was planned, budgeted and contracted. To ensure success, the workshop was supported by a partnership with two other organizations – the Statistical Society of Australia and the APBG (Australian Pharmaceutical Biostatistics Group). ARCS hopes that this model will be followed by other ESCs who identify a need to bring overseas expertise to our membership. A summary of the workshop follows Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=68 http://www.arcs.com.au/ARCS-Newsletter.html At ARCS, we are committed to working with education providers and facilitators to deliver the highest quality workshops combined with excellence in facilitation to provide the best possible learning outcomes for our members. We are pleased to report that the Education Network described in the April 2008 edition of the Newsletter has expanded with the addition of the following facilitators to the ARCS team Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=67 http://www.arcs.com.au/ARCS-Newsletter.html Take a moment to refl ect on the last time you received recognition for an achievement or success. How did it make you feel? And how did it impact your commitment to work? PROUD and ENERGISED are probably common thoughts. So join me in recognising a few recent achievements from the board Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=66 http://www.arcs.com.au/ARCS-Newsletter.html Many of our members may not realise that the Association has, and is committed to a medium term strategic plan. The Board and management of ARCS set aside time annually to work with an external facilitator to consider carefully, and brainstorm ideas around where we want to be in 3 years time. The goal is to ensure the future of the association for its members, to understand its strengths and the opportunities for growth to benefi t members Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=65 http://www.arcs.com.au/ARCS-Newsletter.html As big pharma and biotech look to achieve time and cost savings, functional outsourcing is becoming an increasingly popular model. This article examines the shift towards strategic outsourcing and the impact it may have on the traditional full service CRO model Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=64 http://www.arcs.com.au/ARCS-Newsletter.html In the last edition of this Newsletter, we reported on the Senate Inquiry into the National Health Amendment (Pharmaceutical and Other Benefi ts - Cost Recovery) Bill 2008 (Cth) (“Bill”). The Bill was referred to the Senate Community Affairs Committee (“the Committee”) primarily because of the considerable debate and controversy surrounding the introduction of the cost recovery measures Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=63 http://www.arcs.com.au/ARCS-Newsletter.html Asian countries with a national healthcare system face the same problems as their counterparts in the west, including the perception that the costs of innovative health technologies are responsible for a substantial component of the escalation in overall healthcare expenditure. For several years Asian regulators have been studying the policies and processes implemented in western countries, particularly those which have adopted health technology assessment (HTA) as the evidencebased framework for decisions about reimbursement. As a result HTA, economic evaluation in particular, is on the radar as a potential policy tool, and in some cases has already been formally incorporated into the reimbursement process. Several challenges remain with reimbursement policy in Asia and the application of HTA, including a shortage of trained manpower and expertise, and relatively poor engagement between stakeholders Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=62 http://www.arcs.com.au/ARCS-Newsletter.html Work is increasingly being done in the area of pharmacokinetic (PK) and pharmacodynamic (PD) modelling in clinical drug development internationally. This session provided valuable insight into how modelling and simulation could help design study trials and improve prescribing information. Concepts of PD modelling, its current and potential impact on drug development were discussed. Presenters included Dr Bruce Green (University of Queensland), Ms Melanie Gentgall (Royal Adelaide Hospital) and Dr Helen Kastrissios (Pharsight Corporation). This session was organised by the Clinical ESC and chaired by Dr Elaine Blair Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=61 http://www.arcs.com.au/ARCS-Newsletter.html Well, it certainly was a great night. The ARCS Melbourne Annual Dinner has been a signature event for Melbourne members for many years, now. After a successful dinner event last year at the Arts Centre, we had a tough act to follow. In the search for a venue, Alieh couldn’t go past the grace and ambience of the Melbourne Aquarium. Our keynote speaker, Professor Rob Capon from the University of Queensland, further complemented our oceanic theme by presenting on how marine life has contributed - and still contributes - to the development of food, cosmetics and pharmaceuticals Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=60 http://www.arcs.com.au/ARCS-Newsletter.html Each year, the Medical Information Education Sub-Committee conducts a survey focusing on the activities of its members. The survey consists of two parts; a questionnaire for managers and a questionnaire for individuals. The following information is a review of the data from the 2005, 2006 and 2007 surveys Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=59 http://www.arcs.com.au/ARCS-Newsletter.html The session brought the European and American perspective of Hot Topics in Regulatory Affairs to a packed audience at the 17th ARCS ASC before concluding with the latest initiatives being rolled out in Australia Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=58 http://www.arcs.com.au/ARCS-Newsletter.html This is a brief summary of the presentation given by Dr James Garner at the ARCS Brisbane ESC Seminar on Thursday 16 October 2008. Dr Garner is VP, Clinical and Medical Affairs at Progen Pharmaceuticals, Brisbane Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=57 http://www.arcs.com.au/ARCS-Newsletter.html The 68th Annual Conference of the American Medical Writers Association (AMWA), held in Louisville, Kentucky on 23-25 October 2008 provided an excellent opportunity for medical communicators to network with like-minded peers and further their professional development in medical communication. Two ARCS members provide a brief write-up of their experiences at the annual conference and encourage anyone who has an interest in developing themselves in the fi eld of medical writing, to give AMWA a try Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=56 http://www.arcs.com.au/ARCS-Newsletter.html FEMALE? NO LONGER IN YOUR 30s? FRAMED MASTER’S OR PHD DEGREE SOMEWHERE? If this sounds like you, you might be mistaken for an American medical writer. Understandably, ARCS members with an interest in medical writing may be most interested in knowing the profile of an ARCS medical writer. Unfortunately, we really don’t have suffi cient data (yet) to describe a ‘typical’ ARCS medical writer. Until we have such data, your best bet to gain insight into the life of an ARCS medical writer would be to attend a forthcoming ARCS Medical Writing ESC evening seminar on ‘An introduction to medical writing’ or session at the Annual Congress (ASC Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=55 http://www.arcs.com.au/ARCS-Newsletter.html The highly successful ARCS TGA Industry Day was held for a 3rd time in Canberra on 23rd October 2008. This time the event, attended by 80 participants, was aimed at intermediate to advanced regulatory affairs professionals with a focus on discussing higher level regulatory topics in more depth. Katy King (Regulatory Affairs Training Manager, ARCS) together with Dr John Donohoe (Director, Management Coordination Unit, Office of Prescription Medicines) provided an introduction to the day ahead and emphasised the importance of these types of educational events between industry and the TGA. Dr Donohoe has been the main TGA contact for organising this day and ARCS would like to take this opportunity to thank Dr Donohoe and all the TGA speakers for a very enjoyable and informative day and for providing industry the valuable opportunity to come to Canberra and interact with the TGA Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=54 http://www.arcs.com.au/ARCS-Newsletter.html The Australian Government is updating and streamlining the existing regulatory framework for therapeutic goods in Australia. These ammendments will affect all areas of the therapeutic goods industry. Specific reforms are proposed in relation to Low Volume, Low Value Exemptions (LVLV), default standards, exports (medicines), product licenses, infringement notices, GMP fees and charges, improving access to information, improving arrangements for statutory committees, whole-of-lifecycle pharmacovigilance and suspension from the Australian Register of Therapeutic Goods. There will also be new provisions for the regulation of homoeopathic and anthroposophic medicines, human cellular and tissue products and in-vitro diagnostic devices Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=53 http://www.arcs.com.au/ARCS-Newsletter.html This year, ARCS decided it was time to run a dedicated meeting for more senior members of the Association i.e. those who hold management positions in their organizations. Increasingly ARCS has been incorporating management sessions into the Annual Scientific Congress and has also introduced a suite of training courses to support new managers however this was the first dedicated meeting for Managers. In order to maximize value for attendees, ARCS also arranged a CRO Partnerships forum alongside the Education Forum, and incorporated the Annual General Meeting of the Association during the luncheon session Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=52 http://www.arcs.com.au/ARCS-Newsletter.html In this education report I will be providing an update on two Scholarships which were on offer to ARCS members this year as well as a report on the successful launch of two new workshops in November Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=51 http://www.arcs.com.au/ARCS-Newsletter.html November heralded two significant events on the ARCS calendar… the Annual Melbourne Dinner and the Annual General Meeting of ARCS! In true Melbourne style, the Education Subcommittee held another very enjoyable end of year dinner, this year at the Melbourne Aquarium. In amongst swimming fish, stingrays, sharks and the odd turtle, the crowd at this ‘not to be missed’ sell out event had an enjoyable time catching up on industry gossip, meeting up with old acquaintances and celebrating successes over a few drinks and delicious food. A few days later, overlooking the wonderful views of Sydney Harbour from the Kirribilli Club the 2007/8 ARCS AGM was held in on Thursday 20th November 2008. This was an opportunity to refl ect on the year that has passed and the key achievements for ARCS Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=50 http://www.arcs.com.au/ARCS-Newsletter.html The ARCS Calendar draws to a close with its Annual General Meeting (AGM), held this year on 20th November 2008. The AGM is an opportunity for members to hear from the Board and the Business Office, ask questions about the decisions being made for the Association and its members and elect new Directors. This year the meeting was held as part of the first ARCS Management Forum – we recognise the importance of providing education and networking opportunities for more senior members and plan to build on this first successful experience Fri, 03 Apr 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=49 http://www.arcs.com.au/ARCS-Newsletter.html In the second half of 2008 I had the privilege of completing the NSW Enterprise Workshop which is a 5 month course designed to promote the establishment of new businesses and growth of existing businesses. It achieves this through training sessions on all aspects of running a business including marketing strategies, project management, risk analysis, fi nance, capital raising, presentation skills, market research, business structure and taxation issues, just to name a few! As and added incentive ARCS Members are entitled to a 10% discount to participate in the NSW Enterprise Workshop Thu, 19 Mar 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=48 http://www.arcs.com.au/ARCS-Newsletter.html Today, more than ever before, patient recruitment is a challenge that companies must overcome, and it is imperative that it is done proactively. Delays in patient recruitment and failure to retain patients in clinical trials can consume unnecessary resources.1 Data shows that patient recruitment and retention has the greatest impact on clinical trial costs. Furthermore, a recently conducted study by US business intelligence firm Cutting Edge Information ‘Streamlining Clinical Trials’, asserts that not only does patient recruitment and retention affect direct trial costs, but it also has a huge bottom-line impact when drug trials are delayed, and ultimately new product launches as well Thu, 19 Mar 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=47 http://www.arcs.com.au/ARCS-Newsletter.html This article was originally published by CRFocus (www.crfocus.org) in the UK (N. Bush and A. Cohen; Keep Your Project SAFE - Achieving Project Management Excellence with an Effective Project Management Plan; 18(9) p Thu, 19 Mar 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=46 http://www.arcs.com.au/ARCS-Newsletter.html The Centre for Clinical Immunology and Biomedical Statistics has received R&D accreditation from the National Association of Testing Authorities (NATA). Research & development (R&D) accreditation is a new service offered by NATA. It is an independent means of demonstrating technical competence and skill in research management and is based on an internationally recognised standard, ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories, interpreted for the research environment Thu, 19 Mar 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=45 http://www.arcs.com.au/ARCS-Newsletter.html This is a brief review of the Patient Recruitment seminar hosted by the Clinical Education Sub-Committee in Sydney on the 5th November Thu, 19 Mar 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=44 http://www.arcs.com.au/ARCS-Newsletter.html I can’t think of a single reason why I suggested ‘The Source Document’ as the new title for the ARCS Newsletter. I can think of several reasons though… Thu, 19 Mar 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=43 http://www.arcs.com.au/ARCS-Newsletter.html In recent years the pharmaceutical industry has worked hard to improve marketing practices, including improvements to the industry’s own regulatory mechanisms. However, notwithstanding those efforts, the current regulatory trend is towards increased scrutiny of pharmaceutical marketing practices, focussing on the whole of the relationship between pharmaceutical manufacturer and doctor. In such an environment, pharmaceutical companies must be able to demonstrate that their marketing activities are conducted appropriately and do not seek to improperly infl uence (or have the appearance of infl uencing) healthcare professionals Thu, 19 Mar 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=42 http://www.arcs.com.au/ARCS-Newsletter.html The following article contains excerpts from the Terms of Reference and from the Directions Paper presented to the Minister for Innovation, Industry Science and Research in September 2008. The Final Report is due to be released early in February and this together with the current documents may be found in full at the Department of Innovation, Industry and Research website. The activities of the PISG are separate to, but complement the Cutler review of Australia’s National Innovation System Thu, 19 Mar 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=41 http://www.arcs.com.au/ARCS-Newsletter.html A core part of the ARCS mission is the provision of education and the fostering of exchanges of information and experience in order to enhance the professional competency of members. Consistent with this mission, ARCS continues to look for ways we can add value to this proposition, which includes creating opportunities for members to generate strong networks which will assist them with their professional life Thu, 19 Mar 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=40 http://www.arcs.com.au/ARCS-Newsletter.html Overall, the primary purpose of the ARCS Australia Board has not changed. The Board will continue to have ultimate responsibility to the ARCS membership for the strategy, performance and governance of ARCS Australia (a public company limited by guarantee and registered under the Corporations Act, 2001). Whilst the Board is responsible for oversight of the CEO and the business, the day to day management and function of ARCS Australia is the responsibility of the ARCS Business Offi ce (ABO Thu, 19 Mar 2009 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=39 http://www.arcs.com.au/ARCS-Newsletter.html The main objective was to explore these two unique therapy areas to give a greater insight into whether monitors would like to pursue careers monitoring in specialty areas Thu, 02 Oct 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=32 http://www.arcs.com.au/ARCS-Newsletter.html This informative session was organised by the Medical Information ESC and chaired by Robyn Stone from Roche. Four speakers with backgrounds in clinical research and quality, information management and law provided valuable insight into the challenges that face the pharmaceutical industry in managing information Thu, 02 Oct 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=31 http://www.arcs.com.au/ARCS-Newsletter.html The 3rd Pharmaceuticals Industry Council (PIC) Research &Development Taskforce (RDTF) Forum – “Clinical R&D in Australia: Innovation and Global Competitiveness” was held in Sydney on 2-3 April 2008. The Forum was sponsored by the Australian Department of Innovation, Industry, Science and Research (DIISR) and meeting logistics supplied by ARCS Australia Ltd. The PIC is a peak industry body with membership and support from AusBiotech, Generic Medicines Industry Association and Medicines Australia. The goal of the PIC is to ensure the growth and development of Australia’s pharmaceuticals industry. DIISR is also represented on PIC. The full Forum report and all presentations are available on www.pharmacouncil.com.au on the “Resources” tab. The focus of this fi rst report is on the changes introduced during 2007 and the survey of Forum participants concerning Australia’s global competitiveness Thu, 02 Oct 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=30 http://www.arcs.com.au/ARCS-Newsletter.html ARCS and CDISC (Clinical Data Interchange Standards Consortium) share common goals and aims for medical research. We want to educate our members to understand why we are passionate about standards, we work to share our information among our members, taking our message around the globe and we have key alliances with other organisations working in the medical research space. CDISC is a global, open, multidisciplinary, non-profi t organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata Thu, 02 Oct 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=29 http://www.arcs.com.au/ARCS-Newsletter.html Proposed amendments to the National Health Act 1953 were introduced shortly after the May budget. These amendments provide a mechanism for the recovery of fees from pharmaceutical companies applying for the listing of new drugs, or changes to existing listings, on the Pharmaceutical Benefi ts Scheme (“PBS”) or designation of vaccines for the National Immunisation Program (“NIP”). Although the amendments were intended to take effect from 1 July 2008, concerns about the impact of the changes have prompted a Senate inquiry. In this edition, we provide ARCS members with an overview of the proposed amendments and some of the issues that have been raised as a result. In a subsequent edition, we will provide members with a full analysis of the outcome of the inquiry Thu, 02 Oct 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=28 http://www.arcs.com.au/ARCS-Newsletter.html This research project was set up to provide an independent and robust method of collecting the views of a broad cross section of ARCS members (with a focus on the two biggest areas of clinical research and regulatory affairs) to assist the ARCS Board when charting the direction for the Association with regards to a skills and training recognition process Thu, 02 Oct 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=27 http://www.arcs.com.au/ARCS-Newsletter.html In past Newsletters I have talked to you about the great improvements being made in 2008 in ARCS’ three key platforms for Members: Education Information Networking Whether you are an Observer, a Participant, a Contributor or a Leader of ARCS’ activities, make sure YOU take full advantage of the new opportunities available. The new website is about YOU – YOUR choices and YOUR profile drive what you see, with the key inputs being YOUR Interest Areas and Location Thu, 02 Oct 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=26 http://www.arcs.com.au/ARCS-Newsletter.html Your time to market is ticking away, your clinical trial has stalled as patient enrolment is slowing, everything is in place but you can’t get the patients, what do you do? It’s a question asked by companies time and again when they realise that slow patient recruitment means their study is ‘in rescue’. Data from a CenterWatch survey revealed that in 40% of clinical studies, failure to achieve patient recruitment and retention targets was the biggest cause of delays. Problems such as this have been estimated to cost drug companies up to US$1 million a day in missed sales revenues. This article was originally published by CRFocus (www.crfocus. org) in the UK (P. Westmacott and D. Cockerill; Developing Effective Patient Communication Campaigns - Communicating to Maximise Patient Recruitment; 18(10) p Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=21 http://www.arcs.com.au/ARCS-Newsletter.html The vice-presidential role allows ARCS to have a more defined management structure at the Board level, and to me it is a very great honour. The Board has progressed markedly in its orientation and operation over the years culminating in a very successful external benchmarking assessment in 2007. However, not resting on our laurels, we do need to continue to take stock of our current situation, the evolving environment and to respond and grow. A stronger management team at the Board level will ensure that the organisation will thrive during this time of change Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=22 http://www.arcs.com.au/ARCS-Newsletter.html On 28 March 2008, Medicines Australia set a global precedent for the pharmaceutical industry by publishing its first report of medical education events held or sponsored by its member companies. The report shows that, during the six months to 31 December 2007, there were 14,633 educational events for healthcare professionals held or sponsored by Medicines Australia’s 42 member companies during the six months to 31 December 2007. The requirement for reporting arises from the Australian Competition Tribunal’s (“Tribunal”) decision to affirm a condition on authorisation of the Medicines Australia Code of Conduct (“the Code”) imposed by the Australian Competition and Consumer Commission (“ACCC”). The condition requires companies to submit sponsored event reports twice yearly. In the last edition, we provided readers with a summary of the background to the Tribunal’s decision and, in this edition, we provide a summary of Medicines Australia’s audit of the reports and the action taken by Medicines Australia in response to the key fi ndings. Of the 14,633 events held during the first six month reporting period, there were 52 events identified as potential breaches of the Code. These events have been referred to the Medicines Australia Code of Conduct Committee (“the Committee”) for investigation. Medicines Australia has said that the findings from the investigation will be made public Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=23 http://www.arcs.com.au/ARCS-Newsletter.html An urgent advertising campaign was required to help reach the recruitment target for a study sponsored by Janssen Cilag. A number of sites were involved throughout Sydney, Brisbane and Adelaide for a study in reflux. The strategy of the patient recruitment campaign involved the implementation of an integrated advertising campaign to reach and penetrate the broad target audience quickly and cost effectively. The underlying objective of the advertising was to generate a response in individuals with reflux and heartburn to determine if they were eligible to participate in the study. A far greater level of noise and ‘breakthrough’ of the communication objective was achieved by combining radio and print advertising. This was reflected in the results achieved through the call centre. The call centre operated in real time and screened, qualified, referred and tracked eligible patients to augment recruitment of potential study participants. Qualified subjects were referred electronically on a daily basis to the respective study coordinators at the various sites. Details of the data captured and referrals executed by the call centre can be reviewed in the accompanying tables. As the campaign rolled out, further advertising was pursued (in waves) and a switch made to colour advertisements to generate a greater response Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=24 http://www.arcs.com.au/ARCS-Newsletter.html I was delighted to attend my first ever Grand Rounds recently, at Princess Margaret Hospital for Children in Perth. As an employee of Telethon Institute for Child Health Research (TICHR) managing a global investigator-initiated clinical trial, I attended with a keen interest the launch of the new Medicines Australia Clinical Trial Agreement, and Standard form of Indemnity, now to be used in all Western Australian Public Hospitals Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=25 http://www.arcs.com.au/ARCS-Newsletter.html This one-day workshop, held at the University of Queensland on Tuesday 13th May, was presented by Prof. Evan Siegel, CEO of Ground Zero Pharmaceuticals. The focus of the workshop was on FDA’s procedures for approval of phase I clinical trials under an Investigational New Drug Application (IND), and the challenges faced by small biopharmaceutical companies in getting to the IND. It was sponsored by TetraQ, Queensland Clinical Trials Network and Q-Pharm Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=19 http://www.arcs.com.au/ARCS-Newsletter.html Outsourcing of medical communications materials has become commonplace. However, in an increasingly competitive market, identifying the most appropriate agency to appoint may appear a difficult task. A recent ARCS seminar – organised by the Medical Writing Education Subcommittee, and chaired by Dr Peter Tobin (Roche Products) – A/ Prof. Karen Woolley (ProScribe Medical Communications) and Ms. Cathryn Berry (Meditech Media Asia Pacific Pte Ltd) provided practical insights into how to go about choosing the right agency for a range of medical writing projects. The key elements discussed included: understanding the outsourcing environment, defining needs, assessing resource capabilities and nurturing relationships. From Bridget Jones to briefs, the seminar proved both engaging and informative… Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=15 http://www.arcs.com.au/ARCS-Newsletter.html A PBS education seminar was held in Canberra on 4th December, which was well attended by pharmaceutical and device company representatives, staff from the Department of Health and Ageing, other government agencies, Medicines Australia (MA) and ARCS. The aim of the seminar was to provide an introduction to all aspects of the PBS listing process. In doing so presentations were made covering the entire range of activities required in achieving PBS listing, from sponsor pre-submission meetings to deeds of agreement Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=16 http://www.arcs.com.au/ARCS-Newsletter.html The Administrative Appeals Tribunal (“Tribunal”) is an independent, impartial review body that has statutory power to review certain decisions of the Therapeutic Goods Administration. If you’ve ever wondered exactly what the Tribunal does and how it operates, look no further. This article provides a summary of the role of the Tribunal in reviewing administrative decisions and the procedural steps involved once an application for review has been lodged with the Tribunal Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=17 http://www.arcs.com.au/ARCS-Newsletter.html The Australian clinical research environment underwent significant changes during 2007 with the introduction of new processes, updated regulations and new/updated codes of conduct for researchers and industry. The 2007 ARCS AGEM provided the opportunity to review some of those initiatives and their impact, and look to the year ahead for what it might hold in store Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=18 http://www.arcs.com.au/ARCS-Newsletter.html The highly successful Therapeutic Goods Administration (TGA) & Industry Day was held for the second time in Canberra on the 9th November 2007, and was attended by 80 pharmaceutical and device regulatory representatives. The aim of the seminar was to provide an introduction to industry professionals who are new to the regulatory profession and give them an insight into the regulatory framework within several of the key TGA sections. It also provided overview of common deficiencies in quality data that these TGA sections have compiled over time. The TGA representation was from the Manufacturing Assessment Branch, Drug Safety Evaluation Branch (DSEB), Over the Counter Medicines (OTC), Complementary Medicines, Medical Devices and the Therapeutic Goods Analytical Laboratory (TGAL). There was also an opportunity, during the tea and lunch breaks, for delegates to meet with the TGA speakers Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=14 http://www.arcs.com.au/ARCS-Newsletter.html The electronic revolution of the last 15-20 years has seen an enormous change in the way we live and work. It now seems hard to imagine how we survived without email, mobile phones and the internet. Pharmaceutical companies and research centres pride themselves on being at the cutting edge of scientific technology and medicine, but how quickly have they embraced the opportunities the internet now provides to network, stay informed and work more effi ciently? In an age where environmental concerns see us striving to reduce paper use, projects are more regional/international and we are all asked to do more in less time, it seems reasonable to seek solutions from the electronic world, of which the internet is cornerstone. Do you know how to get the best out the functionality the web now provides? How could it help you or your business better network and save time and money? This 2-part article provides learnings from my own personal journey to become familiar with the vast wealth of resources the internet provides and how these can be used for personal and commercial advantage, particularly in the world of clinical research. Part 1 explores networking, blogs, wikis and forums whilst Part 2, next issue, delves into other tools that can be used to enhance efficiency Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=13 http://www.arcs.com.au/ARCS-Newsletter.html ARCS provides an excellent program to encourage members to become medical writers, and provides information on topics relevant to that profession (for example, this year the Medical Writing Education Subcommittee held evening seminars on ‘International Update on Industry Sponsored Publications’ and ‘The Right Writer for the Job’). In Europe, there is a large professional organisation specifi cally for medical writers called the European Medical Writers Association (EMWA), which holds professional development conferences in spring and autumn each year. The EMWA conference offers foundation and advance training in all aspects of medical writing, and workshops covering regulatory topics and fundamental writing skills. This article reviews my experience of this year’s EMWA Annual Conference Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=12 http://www.arcs.com.au/ARCS-Newsletter.html An effective call centre can help to expedite subject recruitment and is usually the first critical contact point for a potential study participant. Essentially a call centre acts as a big funnel or filter. There is always significant attrition, however a call centre helps enormously by targeting prospective subjects and then ascertaining if they meet the inclusion criteria and are willing to commit to the study protocol. This article addresses some of the key questions raised when deciding whether to use a call centre to expedite patient recruitment Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=11 http://www.arcs.com.au/ARCS-Newsletter.html ARCS and the Drug Information Association (DIA), with headquarters in the USA, share many similarities in their structure and goals. Both are member based organisations which provide a neutral forum for discussions between regulators, researchers and industry on issues relating to therapeutics development and provide opportunities for education, networking and information sharing. Like ARCS, DIA is volunteer driven with Special Interest Groups (SIGs) covering a large set of disciplines and interests. Of course DIA is much larger and attracts approximately 8,000 delegates to its USA meeting in June each year and around 3,000 delegates to its European meeting in March Sun, 22 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=7 http://www.arcs.com.au/ARCS-Newsletter.html This paper discusses some of the issues that influence decision-making by healthy volunteers and patients when invited to consent to participate in clinical research. It is through a better understanding of these issues that researchers will be able to appreciate why people consent, or not, to participate in clinical research and to consider options that might improve recruitment and retention to future studies. This article was originally published by CRFocus (www.crfocus.org) in the UK (L. Gelling and G. Ellis; Factors Infl uencing Decisions to Participate in Clinical Research; 18(10) p Sun, 22 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=6 http://www.arcs.com.au/ARCS-Newsletter.html ARCS would like to welcome Dr Rohan Hammett as the New National Manager of the TGA. Rohan brings a number of important qualities to the role of TGA National Manager, including a distinguished career as a dedicated clinician and academic Sun, 22 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=10 http://www.arcs.com.au/ARCS-Newsletter.html NZACRes was formed from the clinical research focus group to foster and promote clinical research, and is the professional association for clinical researchers in New Zealand. NZACRes holds regular meetings to bring together members of the clinical research community, to discuss issues in the industry and to network amongst peers for over 240 members. We also run our annual NZ Clinical Research Conference where invited speakers from New Zealand and overseas present on topics of interest to researchers Sun, 22 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=9 http://www.arcs.com.au/ARCS-Newsletter.html After 26 years since its beginnings the Medical Technology Association of Australia (formerly the Medical Industry Association of Australia) has come of age and are focusing on the future of medical technology and its role in the Australian healthcare system. The new name is part of a bigger picture strategic plan for the association and the medical technology industry Sun, 22 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=8 http://www.arcs.com.au/ARCS-Newsletter.html The first round of reports in relation to educational meetings and symposia held or sponsored by companies (“sponsored event reports”) was due to be submitted to Medicines Australia by its members at the end of March 2008. The Australian Competition Tribunal (“Tribunal”) affi rmed the decision by the Australian Competition and Consumer Commission (“ACCC”) to impose a condition on authorisation of the Medicines Australia Code of Conduct (“the Code”) which required companies to submit sponsored event reports twice yearly. In this edition, we provide readers with a summary of the background to the decision and in the next edition, we will report on the impact of the publication of the reports, including stakeholder feedback, and any issues that may arise from the publication Sun, 22 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=5 http://www.arcs.com.au/ARCS-Newsletter.html Last issue we introduced some of the tools that exist to improve networking, communication and information retrieval, with some ideas for how these can support your business. In part II of this article, we will explore some different ways to improve efficiency and save money Sun, 22 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=4 http://www.arcs.com.au/ARCS-Newsletter.html New legislation governing the development and authorisation of medicines for use in children was introduced in the European Union(EU) in January 2007 (Regulation (EC) No 1901/2006 as amended - the ‘Paediatric Regulation’). The aim of this regulation is to assist clinical development and ensure availability of high quality and appropriately tested medicines for children aged 0 to 17 years as well as improving information to prescribers on the use of medicines in children. However these aims are balanced against the need to  ensure that there are no delays to the authorisation of medicines for adults or that children are subjected to unnecessary clinical trials. This short article provides a brief summary of this new regulation in Europe as well as its possible impact for Australia Sun, 22 Jun 2008 00:00:00 GMT http://www.arcs.com.au/ARCS-Newsletter.html?guid=3 http://www.arcs.com.au/ARCS-Newsletter.html