Advance registration for this conference has closed, but space is still available! Please contact the RAPS Solutions Center at +1 301 770 2920, ext. 200 for registration options.
Join regulatory affairs colleagues from the New York/New Jersey area for an evening of networking and an expert presentation titled “Preparing for an FDA Advisory Committee Meeting.” This event is sponsored by the RAPS New York/New Jersey Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals. Attendees of this meeting are eligible for 1.5 RAC recertification points.
A presentation to an FDA Advisory Committee is not a scientific presentation; it is a science based communication challenge. Industry scientists are experienced at scientific presentations, which are all about data. An NDA contains data generated from thousands if not hundreds of thousands of hours of research and development efforts. Selecting and presenting the appropriate data to address FDA's concerns and communicating the relevance of these data to the very diverse group of people who constitute the AdCom is a major challenge few scientists experience more than a few time in their career. We believe that success in meeting this challenge depends on a radically different approach to that which is employed at a typical scientific meeting. The most important thing is to recognize the challenge is one of communication, no mater how good the data are, no matter how strong the case for approval is if the AdCom do not understand it, they cannot be expected to come to a favorable view. The skills required for success are teachable. External expert input and review of the science can ensure a balanced presentation and expert guidance on presentation ensures the AdComs understanding. A well-honed presentation will meet both the FDA's needs and educate the Advisory committee about the issues, challenges and ongoing plans. This approach maximizes the chances of a positive outcome.
A dinner buffet will be available for all meeting registrants!
Register today
Speakers:
Jim DiBiasi, Partner; 3D Communications
DiBiasi’s 20 years of experience in business and regulatory communications, tactical counsel, and media and public relations helps clients navigate the increasingly complex and controversial drug and device approval process. Jim has helped numerous pharmaceutical and consumer healthcare companies prepare for contentious advisory committee hearings, helping them set their communications strategy, organize their teams, prepare and deliver their presentations and answer difficult questions. In addition to helping companies prepare, he has repeatedly testified before lawmakers on complicated regulatory matters and has held executive positions with publicly and privately owned companies.
John Dent, PHD, Independent Consultant; John Dent Consulting
Dent’s 25 years of experience as a leader in pharmaceutical R&D at GlaxoSmithKline covered all aspects of non-clinical development in both the Pharmaceutical and Consumer divisions. For the last ten years John was head of R&D for GSK’s Consumer Healthcare. He had worldwide responsibility for all aspects of product development and product safety with R&D labs in the USA, UK, Germany and India. He led the successful development and registration of many products both FMCG and OTC medicines, including OTC Nicorette and Nicoderm and most recently the submission and FDA approval of Orlistat OTC marketed as Alli. Now retired from GSK he is an independent consultant with a focus on process of product innovation, development and registration.
Date/Time: Thursday, 15 May 2008
5:30 pm Registration Opens
5:30–6:30 pm Registration and Networking
6:30–7:00 pm Dinner
7:00–8:30 pm Presentation and Q/A Session
Location: The Inn at Somerset Hills
80 Allen Road
Basking Ridge, NJ 07920
For directions call +1 908 580 1300, or go to Mapquest.com
Registration fees: RAPS members: $55; Non-members: $65
Local Contact: Deborah Flint, Program Committee Chair, +1 973 768 1018
RAPS Contact: Wesley Carr, +1 301 770 2920