Meeting Highlights - June 20

June 15, 2006

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-06-19-2006, Volume 0, Issue 0

Plenary sessions

June 20, 2006

10:00 am - 6:00 pm — PROFESSIONALS POSTER SESSION
Arch St. Bridge, 2nd Floor, Convention Center

10:30 am - 12:00 pm

CBER Hot Topics


Chairperson: Diane Maloney, JD, Associate Director for Policy, CBER, FDA

3:30 am - 5:00 pm

Plenary Session: Update from the FDA Office of the Commissioner


Chair: Charles C. Depew, PharmD ,

GSK

The Office of the Commissioner will provide an overview of the Agency?s agenda for 2007-2010. Discussion will include the Critical Path Initiative, PDUFA IV, Advisory Committees, Risk Minerazation, National and International Public Health Issues, Product Registration and Regulatory Decision Making.

Q and A panel session with the Commissioner, Deputy Commissioners, and other invited FDA officials will follow the presentations. Panelists include Janet Woodcock, MD, Deputy Commissioner of Operations and Chief Operating Officer, Office of the Commissioner, FDA; Murray M. Lumpkin, MD, Msc, Deputy Commissioner for International and Special Programs, Office of the Commissioner, FDA.

5:30 am - 6:30 pm
RECEPTION FOR THE 100TH ANNIVERSARY OF THE FDA


Grand Hall, 2nd Floor, Convention Center

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