Meeting Highlights - June 20
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
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
