Join your regulatory colleagues from across the Chicago area for an evening of networking and an expert presentation entitled, “The Steps to a Successful FDA Advisory Committee Meeting.” This meeting is sponsored by the RAPS Chicago Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals.
Given the Food and Drug Administration’s (FDA) increased scrutiny of clinical and long-term safety, the agency is calling for more public Advisory Committee hearings each year. Good data alone are no longer enough to win approval. In today’s environment, it is critical to prepare a clear, credible and engaging presentation. You must ensure that your team is ready for the most difficult questions in order to sustain credibility and achieve a positive committee recommendation. Most companies are ill-equipped to prepare for this daunting meeting. With so much at risk in a single presentation, all stakeholders must mobilize and have a clear strategy when approaching FDA for market approval. This presentation will provide you with proven steps that will optimize your success before an Advisory Committee meeting.
A light meal will be provided for all meeting participants. Attendees at this meeting are eligible for 1.5 recertification points.
Tuesday, 22 March 2011
5:30–6:30 pm - Registration Check-In, Networking and Dinner 6:30–8:00 pm - Speaker Presentation and Q/A Session
Abbott Laboratories Building AP52 Conference Room AP52-C 200 Abbott Park Road Abbott Park, IL 60064-3500
Directions are available by downloading the printable map (PDF) or by calling +1 847 937 6100.
RAPS members: $35 Nonmembers: $50 » Register Today
Jim DiBiasi, partner, 3D Communications
DiBiasi has been a business executive, lobbyist, marketer, public relations and crisis communications professional and communications consultant and trainer to some of the top scientists and executives at Fortune 100 Companies. He has prepared clients for numerous Advisory Committee hearings and FDA meetings in indications ranging from acute bacterial sinusitis to weight loss, as well as handling controversial topics such as pediatric, over-the-counter cough and cold medications. DiBiasi has crafted scores of presentations and provided speaker and media training and tactical counsel for clients in the public, private, and nonprofit sectors. He also prepared hundreds of key opinion leaders for major presentations at international symposia in a wide variety of indications.
Carol Cooper, RAC, RAPS Chicago Chapter Co-Chair, +1 847 270 3993 Joseph Orlowski, RAC, RAPS Chicago Chapter Co-Chair, + 1 847 948 3516
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
raps@raps.org+1 301 770 2920
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