The Business Process Reforms being introduced by the Therapeutic Goods Administration represent the most significant changes to operations since the agency was established.
On 1 November 2010 the TGA will be implementing a new streamlined submission process, which is designed to deliver increased transparency of requirements and shorter and more predictable evaluation times. Hear the latest about this initiative on 13 September at the 2010 ARCS Canberra Congress.
In response to your requests the programme will incorporate the key TGA personnel responsible for the changes, as well as panel members from the BPR industry working group, representing both the innovator and generic industry in Australia.
Click here to register now!
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!
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. On Thursday and Friday 520 registered delegates enjoyed the new venue and the high-quality program without hindrance.
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 on the basis of better use of evidence in their arguments. The Affirmative argument was ably presented 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. 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. 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. 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.
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.
Canberra will be a cracker – how will it rate against Sydney?
Time will tell. Don’t miss out!
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