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
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.
