http://www.arcs.com.au/ en-au http://www.arcs.com.au/NewsDetails.aspx?NewsID=67 We are two nurses at the University of Western Sydney who are researching the role of the research nurse/clinical trial nurse in the Australian context. It is important to do this as there are no nationally recognised documented roles for these nurses in the Australian context. If you are interested in being part of this project, please use the link below to access the survey. Research and Clinical Trial Nurses Questionnaire Please see the Participant Information Sheet ( Participant Information Sheet(36.83kB)) for information about the research project. Thank you for helping us with this research project. Professor Lesley Wilkes Professor Debra Jackson Fri, 03 Sep 2010 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=66 Our small dedicated office has been moving forward with new initiatives and growth in line with the ARCS Strategic Plan. We are putting in place the necessary steps to support the ARCS Asia organization that will be formed shortly. The audit has been completed and our large-scale return to Canberra on track with over 420 registrants so far. There have been some Board changes with Sian Slade and Andrew Taylor both recently moving overseas and us welcoming two new directors Sarahann Simpson and Teresa Schafer to the Board. In addition Katrina Campion, our ARCS President has been selected for short-term volunteer work in Washington D.C., which she is ably managing in addition to her ARCS commitments. Within the ARCS Business Office, Bridget, Penny and Joe continue as dedicated stalwarts of the organization. Belinda King has had a baby boy, Rondo, and is on maternity leave - her role of Education and Events Coordination is being covered by Elizabeth Quinn-Joya. Katy King (Regulatory Affairs Manager) has had a baby boy, Rohnin, and moved to Lismore with her husband. Katy’s maternity leave replacement Theresa Dickson-Bogie continues to deliver the regulatory courses for ARCS. George Azoury has joined us in a Regulatory/HE and Quality project management capacity as the Regulatory Affairs Training Manager. In coming months, Paula Mackie (currently Clinical Research Training Manager) will transition to become the ARCS Clinical Projects Manager, allowing her to pursue her passion for e-learning and education development with ARCS. To replace this role as well as to expand our offerings, we have advertised for an additional headcount in the form of a Medical Education Manager. For those of you who may not have heard, Marisa is enjoying her new role at George Clinical but is not too far away, and remains involved with some key strategic initiatives, and Adrian is settling in nicely.A last bit of news is that we will expand further in 2011 so watch this space! Kind regards, Adrian Bootes and Joe Badolato Fri, 27 Aug 2010 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=65 On 17th August members of Pharma (including the PIC Research and Development Taskforce) and other local high tech industries, were invited to a small forum with the local member for Bennelong Ms Maxine McKew and the Minister for Innovation, Industry, Science and Resources, Senator Kim Carr. Questions from the Pharma attendees were around the Clinical Trial Action Group (CTAG), R&D Tax Credit and support for Pharma in general. Of great interest to our clinical members is the undertaking from Senator Carr that the overdue Government CTAG response, has being internally negotiated and is ready to be released shortly after the election. Senator Carr indicated that the recommendations from the report seemed reasonable. The R&D tax credit legislation has yet to make its way through Parliament; however Senator Carr was hopeful of an implementation date of 1 July. Direct support for CSL, reduction in company tax rates, high-speed broadband and North Ryde transport links, were other measures planned that would affect Pharma locally and nationally. Adrian Bootes and David Lloyd Thu, 19 Aug 2010 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=64 After consultation with many local Pharma companies, CROs, DHBs and Universities, a standard Indemnity and Compensation Agreement (sICA) was created and released in November 2009. Following feedback from industry the sICA has been modified slightly and has now been released as Version 2 (dated July 2010) and has been released via the NZACRes web site www.nzacres.org.nz. While there were a number of new issues raised post-release the most common issue was that of a reference to third parties in Clause 3a. This has been removed and revised wording inserted. It is hoped that this makes Version 2 more palatable to a wider range of organisations. Also note that the Guidance Document has been updated as well. There has been wide consultation across DHBs regarding this modification and therefore it is envisaged that all DHBs (and some other research providers) will prefer to use this sICA without modification. However, the use of the sICA is not compulsory rather it provides an opportunity to streamline indemnity requirements in the start-up of sponsored clinical trials. Our thanks must go to the people who have been involved in this process over the past 18 months. Special thanks to the writing group for addressing the issues raised and completing the task Tue, 27 Jul 2010 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=59 A working group associated with the NZ Association of Clinical Research is developing a standardized CTRA along the lines of the Agreement developed in Australia. It will include a Schedule 7 and they are currently seeking input on Schedule 7 changes that have previously been requested when using the Medicines Australia templates. The sCTRA Working Group would like to consider adopting any commonly requested changes in the main body of the first draft of the agreement. A review process and timelines will be released at a later date in order for stakeholders and other members of the clinical research industry to submit substantive feedback on the first draft agreement. Please email your Schedule 7 items to be considered by the sCTRA Working Group by close of business Thursday 15 July 2010 to info@nzacres.org.nz with the subject line “sCTRA Working Group” Tue, 27 Jul 2010 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=62 Commencing 1 July 2010, for multi-centre research studies, a single QH Human Research Ethics Committee (HREC) now conducts the ethical and scientific review on behalf of all QH sites at which a research study is to be conducted, thereby eliminating the need for each local QH HREC to conduct its own review. Submission of all multi-centre research studies to a lead reviewing QH HREC is through the QH Central Coordinating Service (CCS) located at the Research Ethics and Governance Unit (REGU), Office of Health & Medical Research. Once HREC approval has been granted, researchers will still be required to submit a Site Specific Assessment (SSA) Form, for each participating site, to the local Research Governance Officer(s) to obtain District authorisation to commence the research. Further information on the QH single ethical review process and how to submit a multi-centre research study for ethical review can be obtained from: The Research Ethics and Governance Unit (REGU) website: http://www.health.qld.gov.au/ohmr/html/regu/multicentre_research.asp Contacting the CCS information lines on 07 3234 0654 or 07 3234 0034 The Researcher User Guide (RUG): http://www.health.qld.gov.au/ohmr/documents/researcher_userguide.pdf Wed, 14 Jul 2010 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=56 This was so great – and it is only the beginning! The “second half” of ARCS Scientific Congress for 2010 is coming up in September and registrations open in July! Read on to reflect on Sydney or to see what you missed! Wednesday 26th May proved to be one of those rare but memorable Sydney days with torrential rain and howling winds. This was the day all the Exhibitors and the Business Office staff needed to set up the Congress, and for me, there was more than a little anxiety about how we would manage if the weather continued – contingency plans were well underway! However, the gods were smiling on ARCS, the rain and wind abated and on Thursday and Friday 630 delegates were able to enjoy the new venue and the high-quality program without hindrance. And my blood pressure returned to normal. 2010 is the first year of a new format for Congress – 2 days in Sydney focused on research and development, and 2 days in Canberra focused on registration, regulation and reimbursement. Splitting Congress means a smaller attendance at each – we were delighted with the numbers in Sydney (60% of the 2009 total) and expect to exceed this in Canberra given interest to date. A smaller delegate numbers means much greater choice of venues and we chose the Australian Jockey Club facilities at Royal Randwick this year – a great choice as it turned out with large, airy rooms with natural light streaming in, views out across the racetrack, plentiful complimentary parking and a fabulous staff who could not do enough for us. Innovation was also strong in the Program Stakes. The Opening Plenary took the form of a debate: That Commercial Interests Threaten the Integrity of the Medical Literature more than Non-Commercial Interests. This serious topic was well developed by both teams and the novel format enabled humour and time honoured debating techniques to be woven into the arguments. The debate was judged by both the audience and a panel of judges, both groups awarding the debate to the Negative Team of Dr Karen Woolley, Dr Russell Basser and Mr Will Delaat on the basis of better use of evidence in their arguments. The Affirmative argument was ably presented by Prof Colin Thomson, Prof Paul Komasaroff and Dr Martin Van Der Weyden but they were unable to sway the judges with their arguments. The debate was both enjoyable and intellectually stimulating for the audience who were treated to a passionate presentation of both arguments. The bar was set at a very high level by the debate, but the ensuing Concurrent Sessions on Day 1 were very well received – creating considerable discussion and enthusiastic exchanges of information by delegates during breaks in the Exhibition Hall. The attendees voted Cindy Hall as Best Speaker on Day 1 – Cindy is a Clinical Research Manager at Princess Alexandra Hospital, Brisbane and she spoke in the session titled: Linking Employee Engagement to Effective Deliverables in Clinical Trials. This was a fascinating topic linking personnel management with the ability to deliver on clinical trial metrics such as recruitment. This session rated well, however the session voted by delegates as the best on Thursday was Conducting Clinical Trials in large Asian Markets – a session submitted by the Asia Pacific ESC and chaired by its (retiring) Convenor, Cheryl Townsend. Congratulations to Cheryl and Cindy who each received a Winners Ribbon (a “racing rosette”) and a Myer Voucher. Friday dawned with sunshine – a good thing after the enthusiastic involvement of delegates in the Conference Dinner activities. There was “betting” on phantom races, Fashions on the Fields, food, wine and dancing late into the night. Friday morning saw the introduction of half-day workshops – 5 sessions all of which were developed and run as highly interactive and effective workshops from 9am until 12.30pm – enabling more in-depth treatment of the topic and practical application of the learnings. Feedback was excellent, and I want to thank all the Workshop leaders and speakers who put a tremendous amount of time into developing these valuable sessions. Deborah Monk, who developed and ran the workshop on the Implementation of the New MA Code of Conduct was voted Best Speaker for Friday, whilst one of the afternoon sessions Perceptions versus Reality in Managing Studies in Asia Pacific was voted as Best Session. This session was submitted by Kendle Australia, and chaired by Ric DeGaris of Kendle. Congratulations to Deborah and Ric who received prizes as noted above. The final session of the Congress was a plenary with a difference! To the pulsing beat of Madonna’s Express Yourself, Dr Joe Badolato from the ARCS Business Office ran a very successful Express Learning session where delegates had the chance to choose from over 20 topics and participate in three 20 minute discussions with subject experts. To help get in the mood for the Closing Drinks, attendees were treated to a wine tasting at each of the change-overs – with wines sponsored by NSW Wine Society. Joe is to be commended on developing and managing this session – another great innovation for ARCS Congress! Whether you were there, or sorry you weren’t……do make sure you talk to your manager about registering for Canberra and/or ensuring budget is available for the 2011 ARCS Congresses. For those who were there – be sure to share your learnings with your manager and thank them for supporting your attendance. Share your new knowledge with your colleagues and make sure you implement those key learnings, making the most of this professional development opportunity. Canberra will be a cracker – how will it rate against Sydney? Time will tell. Don’t miss out Thu, 03 Jun 2010 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=48 Programs for BOTH the Sydney and Canberra conferences are now available on the website - Registration opens for Sydney in March and for Canberra in July. Start planning now Mon, 08 Feb 2010 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=45 senior ARCS members took advantage of a program specifically designed for managers and leaders at the ARCS Management Forum on 22nd October 2009. Feedback included: "I found the content and quality of the ARCS Management Forum top rate. Lots of relevant material and in conversation with my MD the next morning easy to give him relevant update and convince him of the excellent value for money. " Jeremy Simpson, Director- Scientific Affairs Pharmatel Fresenius Kabi Pty Ltd "It is invaluable to join with management colleagues to hear industry leaders comment on the current landscape. The Forum provides time to discuss and reflect upon the future of the Industry and my organization’s role therein." Meg Hooton, Associate Director Clinical Operations, Quintiles Don’t miss the 2010 event – already scheduled for Wednesday 27th October 2010 – block the day Thu, 05 Nov 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=27 ARCS is delighted to announce the appointment of Insurance House Group as our preferred Professional Indemnity insurance provider for members. Insurance House Group has been established for 25 years, employs 55 staff and is one of Australia’s largest privately own insurance brokers. They are innovative, professional and dedicated to protecting clients. ARCS has reviewed the capabilities of Insurance House Group and is confident they can deliver the insurance solutions members need, with: A dedicated member service team In-depth industry knowledge Tailored policy coverage Access to all insurers Competitive premiums In-house claims teams As a full service insurance broker Insurance House Group can also assist with other member insurance needs, both business and personal. For more information visit: http://www.arcs.com.au/My-Benefits.html Wed, 04 Nov 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=37 NHMRC’s Council has agreed with a recommendation from the Australian Health Ethics Committee that a minor amendment be made to the 2007 National Statement on Ethical Conduct in Human Research. This change affects the chapter on People with a cognitive impairment, an intellectual disability or a mental illness (Chapter 4.5). Details of the change are available on the NHMRC website Wed, 04 Nov 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=29 The NSW Department of Health has updated its policy directive on the use of standard CTRAs. There is no substantive change, except for the inclusion of CRO CTRA. To review the changes, please visit the NSW Health website and scroll down to the section titled Clinical Trial Research Agreement. Visit the website at http://www.health.nsw.gov.au/ethics/research/governance.asp Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=30 NHMRCs Australian Health Ethics Committee has developed a revised Position Statement: Monitoring and Reporting of Safety for Clinical Trials Involving Therapeutic Products. This statement replaces the HREC Alert issued by NHMRC on 18 April 2007 and clarifies the requirements for safety monitoring, reporting and review of clinical trails. The revised Position Statement is available on the NHMRC website. ARCS will be conducting an Evening Update (seminar and webinar) on 27th July 2009 to provide further information. More information to follow Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=28 During the local NZACRes meeting in Auckland on the 12th June, the proposed final version of a NZ indemnity template was presented. This document - once it is finalized and agreed - will be an important milestone for a better infrastructure of Clinical Research in New Zealand - as it will facilitate study startup significantly. The draft indemnity document was prepared by a working group of DHBs, with input of the national DHBs lawyers group. Some valuable comments were received before and during the meeting. The document is now open for consultation. A MS-Word version is available on the NZACRes web page under News: http://www.nzacres.org.nz/news/documents/DRAFT%20NZ%20DHB%20Standard%20Indemnity%20Jun09.doc. Feedback is invited and can be submitted to info@nzacres.org.nz - deadline is 3rd July, 2009. After the end of the consultation process a round-table of the writing group and interested people will review the feedback and finalize the document. Individuals who would like to part take in the round-table discussion should express this by email also by 3rd July 2009 to info@nzacres.org.nz Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=26 In these harsh economic times when many businesses and activities are seeing a downturn, the ARCS 18th Annual Scientific Congress defied the odds by attracting 1,168 delegates – a 5% increase on last year’s figures. Run from the 1 – 3 June 2009 at the Sydney Convention and Exhibition Centre, delegates were again treated to an extensive range of scientific sessions – 44 in total (10% increase on 2008) - focused on the latest information and facts on what’s happening in the therapeutic development arena. To coincide with the theme “Education into Practice”, the 2009 Congress introduced daily brainstorming sessions whereby delegates came together to share what they had learned that day and identify three elements they would implement back in the workplace. This concept was well received as it helped reinforce, in both the delegates and their managers, the value of attending the Congress. With the large range of sessions, this year, we were able to attract a vast array of attendees, with the delegation consisting of Team Leaders & Managers (32%), Associates (30%), Senior Associates (15%) and CEO/GM/Director/Senior Management (14%) who were predominately employed in Clinical Research (31%), Regulatory Affairs (30%), Medical Information (8%), Health Economics (6%), and Pharmacovigilance (6%) within the industries of Prescription (52%), CRO (9%), Biotech (8%), Government & Academia (5%), OTC & Complementary (3%) and Devices (2%). So far feedback from delegates has been extremely positive: “Just wanted to write and let you know how much I enjoyed the ASC this year. The topics were relevant, and the sessions were well organised and informative. Thats a great effort as I know how much work goes into the organisation of each session. Congratulations to you and the organising committee!” “A quick note to thank you and the team for an excellent meeting. All the presentations I attended on days 1& 2 were interesting, informative and well delivered - and the opening session on QUM was just terrific! I liked the innovation of getting us to put our key learnings and actions down on paper - focused the mind pretty well!” Although the 2009 Congress has only just finished, planning for 2010 has already begun! Be sure you put your budget requests in now so you too can be one of the 1,000 expected to attend next year Thu, 06 Aug 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=32 ARCS is pleased to be associated with the Clinical Trial Magnifier 2009 Conference as a Supporting Organisation. The Conference will be held on November 13-15, 2009 at The University of Hong Kong. We encourage you to provide this information to your affiliate organizations conducting research in the Asia Pacific region. Earlybird and Group Registration discounts apply. Earlybird closes 31st July 2009. Program information and all conference details are available at www.CTMConference.com. Fri, 24 Jul 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=31 Queensland Health (QH) tendered has appointed DLA Phillips Fox to provide legal services across all sites in QH for the review and advice on non standard clinical trial/research agreements. This initiative should assist in streamlining the legal review process and assist Districts in accessing timely and consistent advice and direction on non standard agreements. All the District lawyers have been notified and all requests for contract review are to be sent through the District lawyer, who will initiate contact and request services Fri, 24 Jul 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=11 Do you want to undertake a research project, expand your own knowledge, raise your profile within ARCS and help to increase the knowledge of other ARCS members? If so, would $10,000 help? If the answer is yes, why not apply for this year’s Osmond-Russell or ARCS Original Research Scholarships. Scholarship 1: Osmond-Russell Scholarship (Professional Development Grant) The aims of the Osmond-Russell Scholarship (Professional Development Grant) are to encourage ARCS members to improve their skills by pursuing study in areas that may be of interest to the ARCS membership, or attending international conferences on topics relevant to the membership. Scholarship 2: ARCS Original Research Scholarship This new Scholarship has been developed to support ARCS members undertaking original research projects which contribute to our understanding of the therapeutics development process and are therefore relevant to the ARCS membership (see Catrina Codd’s project from 2004). To find out more or to apply visit http://www.arcs.com.au/Osmond-Russell-Scholarship.html Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=10 From its humble beginning, with issue Number 1 in April 1985, the ARCS Newsletter has come a long way! It is now much more than just a company "Newsletter" – it is now a valuable industry information source and a well received publication and member benefit. Therefore, we would like to invite you to help us rename the ARCS Newsletter to a more fitting name. To suggest a new name for the ARCS Newsletter, please email the ARCS Business Office at arcs@arcs.com.au. The winning entry will receiving a $50 Myer Voucher and the new name "Up in Lights (on every bi-monthly issue)" for years to come! Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=15 The Sponsorship and Exhibition Prospectus was released just over a week ago and we have already sold over 80% of available space! We have also secured Gold Sponsorship for Pharmaceutical & Medical Professionals and Bronze Sponsorships for Cryosite, i3 Pharma Resourcing and Roche Products. If you are interested in exhibition and showcasing your company to over 1,150 delegates, from the therapeutic goods industry, research institutions, academia and government download the Prospectus today! Register early to avoid disappointment Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=14 ARCS Australia Limited ABN 25 050 334 444 NOTICE OF MEETING Notice is given that the Annual General Meeting of members of ARCS Australia Limited (ARCS) will be held at the Kirribilli Club, Harbourview Cresent, Lavender Bay NSW on Thursday 20th November 2008 at 1.00pm. Members may click here for access to all documents. To register for the Education Forum, and explore the secrets of working within and managing high performance teams, the CRO Partnership Forum, to make appointments for private meetings with 1 or several CROs all on the same day!, and attend the ARCS AGM, click here! Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=13 ARCS 18th Annual Scientific Congress 2009 will be held at the Sydney Convention and Exhibition Centre from 1st - 3rd June 2009. We anticipate well over 1000 delegates from the therapeutic goods industry and from research institutions, academia and government. This is a premier Australian event for those involved in the development of therapeutic goods. Members and non-members of the Association are invited to submit a Session Abstract in accordance with the Guidelines. Please ensure this is completed and submitted via the web link provided in the Guidelines before Friday 7th November Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=12 Were you one of the people who anonymously showed an interest in being on the ARCS Board during the opening session of the ARCS Scientific Congress? Or… Are you wanting to find out more about what it means to be on the Board? The new ARCS constitution which was passed at last years Annual General and Education Meeting (AGEM) requires four Board members to step down this year leaving those positions vacant. All Full and Life Members of the Association may nominate and wed all love to hear from anyone who has an interest in taking an active part on the ARCS Board. Ideally a strong Board will reflect the diversity of the membership of the Association. If your experience and interests complement those of the Directors who will remain on the Board for the coming year (Katrina Campion, Adrian Bootes, Amanda Jubb and Sumith Nawaratne – see their bios at www.arcs.com.au/Board.html) please seriously consider nominating for a role on the Board. If you have an interest and would like to understand more, please contact Katrina.J.Campion@GSK.com Wed, 17 Jun 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=17 ARCS is committed to continuing to deliver educational and networking opportunities for its senior members and those in management positions. 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. The response to the concept and the program was very supportive – this is something that has been lacking and ARCS was commended for addressing it. Attendees were asked for feedback on preferred dates, and the Management Forum will be scheduled in late October in 2009, so stay tuned for the date Fri, 29 May 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=18 An election was held at the 2008 ARCS AGM on 20 November 2008 to fill four vacant Director positions (half the Board stood down as required by the Constitution, and 3 renominated) from six nominations. We congratulate the successful candidates who will join the Board for the next two years: James Bryden Sian Slade Andrew Taylor Gillian Waddell, and join the continuing Directors: Adrian Bootes (Vice President) Katrina Campion (President) Amanda Jubb Sumith Nawaratne Fri, 29 May 2009 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=9 A joint taskforce between the ARCS Clinical Quality Compliance ESC and the Pharmaceuticals Industry Council R&D Taskforce has been set up to find solutions for problems arising from CRAs being denied access to electronic medical records systems necessary for clinical research. A briefing paper for hospitals, government and research institutions has been prepared to raise awareness of the problem and to assist in finding a solution. Any feedback would be welcomed by the convenors of this working group Fri, 01 Aug 2008 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=6 Yes – its over for another year, but it was a great success! 1052 registered delegates enjoyed the Congress – and in total, 1150 interested parties walked through our doors which included final year and post-grad students interested to know more about opportunities for careers in therapeutics development, visitors to the Exhibition Hall, and of course a large number of members and non-members attending the education sessions. ASC is ARCS flagship event, an event we aim to deliver to International standards (for half the price) and our success was confirmed by several of our international and keynote speakers. 41 sessions – an increase of 20% on 2007 - meant 123 speakers and 41 sessions chairs gave their time to develop sessions which explored new advances in the many facets of therapeutics development (clinical research, Asia Pacific development, quality issues, regulatory affairs, pharmacovigilance, data management and statistics, health economics), the communication of research results and medical information to the broader community, workplace management skills and leadership development Wed, 02 Jul 2008 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=5 They may not be dressed in white lab coats, but the scientists who attended the educational day and Annual General Meeting of the Association of Regulatory and Clinical Scientists (ARCS; www.arcs.com.au) in Sydney on Thursday (23 Nov. 2006) know they play an important role in developing potentially lifesaving drugs and devices. These scientists also know they can’t do their job properly without ongoing professional development, and this is why their association, ARCS, is so important to them. ARCS, a company limited by guarantee, has historically kept a low profile. However, ARCS is Australia’s oldest and largest association for scientific professionals who bring new drugs and devices to the market. ARCS was founded by scientists for scientists. Thanks to many dedicated volunteers, this association, which has been successfully run by scientists since 1984, now provides ongoing professional education and networking opportunities for more than 2000 members in Australia and New Zealand. What started out as an association for clinical and regulatory scientists has now expanded to serve scientists working in many specialised disciplines including medical information, health economics, medical writing, statistics and auditing. At the AGM, the ARCS President and Chair of the Board, A/Professor Karen Woolley, highlighted that “ARCS’ strong financial position is a credit to the members, management and Board of ARCS, and reflects well on the new strategic plan and corporate governance practices embraced this year.” The CEO of ARCS, Dr Marisa Petersen provided members with a comprehensive summary of the achievements of the Association in the past year. As noted by Dr Petersen “ARCS has broadened its educational offerings in the past year, complementing its current training and seminar program with relevant material sourced both locally and internationally. ARCS is regularly working with government departments and regulators to ensure there is consultation with its members and accessible information and training. ARCS is also adopting a higher profile with industry and government leaders to better position the profession, and to assist its members with skills development in times of increasing skills shortages.” Testament to the dedication that these scientists have for their company, the Board of Directors gave up at least one celebratory champagne to have their first meeting immediately after the AGM. The members elected to serve on the ARCS Board for 2007 are: Ian Adams (GlaxoSmithKline), David Ali (The George Institute), Adrian Bootes (Roche), James Bryden (Abbott), Katrina Campion (GlaxoSmithKline), Sue O’Malley (Medical Intelligence), Andrew Taylor (Roche) and Gillian Waddell (Mulbrae Clinical Strategies). A/Professor Karen Woolley (ProScribe Medical Communications) was elected unopposed to continue to serve as President and Chair of the ARCS Board. The importance of ensuring that ARCS remains an effective and sustainable organisation was reinforced by A/Prof. Woolley. She warned that “without well-educated scientists, who remain up-to-date with the latest regulations, technological advances and ‘best practice’ processes, the development and testing of new drugs and devices in Australia could come to a grinding halt.” The fact that these scientists have access to a successfully run association that is focused on providing ongoing professional development is reassuring…not just for ARCS members perhaps, but for all of us whose future health might depend on one of the new drugs or devices these scientists are working on now! ### Interview contact: Dr Marisa Petersen, CEO ARCS Business Office Suite 904, 28 Clarke St, Crows Nest, NSW 2065 Phone: 02 8905 0829 Fax: 02 8905 0830 Email: marisapetersen@arcs.com.au Web: www.arcs.com.au Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=4 The Drug Information Association (DIA) and the Association of Regulatory and Clinical Scientists to the Australian Pharmaceutical Industry Ltd (ARCS Australia) announce a collaboration enabling ARCS Australia to license content for six of DIA’s best-in-class training courses. "DIA is pleased to be working with ARCS Australia as a strategic partner in helping achieve DIA’s mission," explained William Brassington, Acting Executive Director. "By providing educational content that is relevant to professionals involved in drug development, this alliance helps DIA create a presence and extend its brand in global markets such as Australia." "Both the DIA and ARCS are committed to the exchange of information and provision of education for their members," noted Marisa Petersen, CEO of ARCS. "This agreement allows ARCS to deliver best-in-class training courses and modify current DIA content to the Australian and New Zealand environment. This enables us to meet our aim of promoting education in the areas of regulatory affairs, clinical research, health economics, medical devices, diagnostics and medical information in order to enhance the professional competency of our members." Courses include: Advanced Topics in Clinical Research/Drug Development highlights product development strategy, clinical trial management and development, project management, and quality concepts. Clinical Statistics for Nonstatisticians provides an introduction to basic statistical concepts fundamental to clinical research, for professionals who have regular exposure to statistics either through studies or professional experience. Advanced Clinical Statistics for Nonstatisticians addresses topics such as modeling, multiplicity adjustments, non-inferiority, PK/PD, data mining, adaptive designs, Bayesian Principles, and survival methods. Fundamentals of Project Management: What Everyone Involved in a Project Needs to Know teaches the fundamentals of the project management process, as well as a set of project management skills that can be immediately put to use. Overview of Drug Development outlines how new pharmaceutical products are identified and developed under FDA regulations and ICH guidelines. Project Management focuses on the elements of a project plan, how to use the plan to execute and control a project, and how to motivate team members to achieve measurable goals. As part of this collaboration, DIA is also offering e-membership to ARCS members for US$65 annually. This includes access to all DIA electronic publications, as well other standard DIA member benefits, such as: Volunteer opportunities as a speaker, session or track chair, author, or Special Interest Area Community (SIAC) member Discounted registration fees for most educational offerings Access to the Job Bank, Membership Directory, and Member Discount Program ### Contact: Australia: Marisa Petersen, 02 8905 0829, MarisaPetersen@arcs.com.au USA: Jennifer Andree-Webb, 215-442-6128, Jennifer.Webb@diahome.org About ARCS ARCS is the professional development Association supporting scientists working in the development of therapeutic products in Australia and New Zealand. ARCS is a premium provider of education services and networking opportunities for its members and stakeholders associated with the industry. ARCS conducts seminars, training workshops and conferences across the range of clinical research disciplines and in regulatory affairs, health economics, pharmacovigilance, medical information and medical writing. For more information, visit www.arcs.com.au or call 02 8905 0829. About the Drug Information Association (DIA) The Drug Information Association serves more than 18,000 professionals in the biotechnology, pharmaceutical and regulatory industries worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, Pa., USA, and with offices in Basel, Switzerland and Tokyo, Japan, the Association is led by its volunteer-based board of directors and executive management team. For more information, visit www.diahome.org or call Mon, 23 Jun 2008 00:00:00 GMT http://www.arcs.com.au/NewsDetails.aspx?NewsID=1 The Annual General Meeting of the Association of Regulatory and Clinical Scientists to the Australian Pharmaceutical Industry Ltd (ARCS) yesterday voted to change the name of the Association to ARCS Ltd and to adopt a new Constitution. These moves were designed to reflect the increasingly diverse roles of its 2000+ members - no longer just regulatory affairs and clinical research professionals. These moves also allow ARCS to encompass a broader industry sector - no longer just the pharmaceutical industry, but the much broader ‘therapeutic goods’ sphere. The name ARCS Ltd will be used together with the tag line – Professional Development for the Therapeutics Industry™. The new Constitution also ensures compliance with the Corporations Act 2001 and corporate governance good practice. ARCS is a member-based professional association with a mission to provide high quality education for its members. ARCS provides regular Information Bulletins (covering key updates and industry news), training workshops, a seminar program developed by 11 special interest groups and conferences. The new Constitution reinforces the professional standards expected of its members and provides for a new Class of membership called Overseas Associates. This Class will encourage membership from the various countries with an interest in the Australian research environment and ARCS’ services. The goal of the Association is to be able to meet the needs of this group more effectively in the future through e-learning and the development of co-operative agreements with organisations in their country. This AGM brought to a close two very productive years as President of the Association for Prof Karen Woolley who has focused the Board’s attention on bringing its corporate governance activities into line with good practice. The incoming President, Katrina Campion expressed the thanks of all the membership when applauding Prof Woolley’s wonderfully passionate and energetic leadership for the Association. At the AGM, ARCS’ Professional Development Manager, Dr Joe Badolato, also announced that the ARCS Board will introduce a second scholarship for members, which will support contributions towards original Australian research. This second scholarship is in keeping with the changing nature of the ARCS membership and complements the aims of the Osmond-Russell Memorial Scholarship, which was introduced in 1987 to enable skills development through study or research opportunities. Alongside the AGM, attendees were treated to a full day of professional development sessions, led by a keynote session dedicated to exploring the Medicines Australia Code of Conduct and how it applies to those involved in the development and marketing of therapeutic products. The session, chaired by Deborah Monk (Director, Innovation and Industry Policy at Medicines Australia) examined the important relationship between industry and physicians/researchers. The session speakers challenged the audience to think of how to manage this relationship appropriately in order to maximize the important educational role of industry for the medical profession whilst maintaining public confidence that this relationship is not being exploited for commercial gain. For more information contact: Marisa Petersen, CEO, ARCS, 02 8905 0829, marisapetersen@arcs.com.au Fri, 20 Jun 2008 00:00:00 GMT