|Articles|June 15, 2006

Applied Clinical Trials

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

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


Related to this article

© photon_photo - © photon_photo - stock.adobe.com
Standardized measurement across five oncology centers found that clinical research coordinators rated eSource-enabled workflows positively (Overall Mean Satisfaction 5.79 of 7), with reduced manual entry and electronic data transfer earning strong marks, while perceived reduction in sponsor and monitor queries lagged as the one domain below threshold.
Where the Industry Is Headed as Clinical, Operational, and Real-World Data Connect
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, describes the industry’s trajectory toward a unified intelligence orchestration environment—and explains why the future isn’t one model that knows everything, but a trusted system that brings the right evidence to the right human decision.
What Expanding AI Ecosystems Mean for Sponsor Complexity and Oversight
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, argues that CROs must act as orchestrators rather than aggregators—and that the real test of any AI ecosystem is whether it reduces sponsor coordination burden or just hands it back to them.