Implications of the FDA’s Updated Definitions for Standardized Data Collection for Cardiovascular Trials
4th May, 2010
Time: 11:00 - 12:00
Time: 11:00 - 12:00
On March 26th 2010, the FDA hosted an event on the Standardized Data Collection for Cardiovascular Trials. Participants of this event included members from the FDA, EMA, Health Canada, the Japanese Regulatory Agency and leading academic adjudication committees who met to finalize the accepted endpoint definitions for cardiovascular trials. This webinar will review how these changes will affect your drug pipeline.
Topics to be covered:
- Why the updated definitions will influence the design and scope of cardiovascular safety studies.
- How type 2 diabetes drugs will be subject to new FDA guidance for the assessment of cardiac safety.
- Why sponsors must complete rigorous assessments of cardiovascular outcomes pre- and sometimes post- approval.
- Independent adjudication of cardiovascular outcomes and solutions to help accomplish these processes.
Who should attend?
Professionals in Medical Affairs, Clinical Operations, Regulatory Affairs, Marketing, and Medical Writing
Expert Panelists:
Dr. C. Michael Gibson, MD FACC
Dr. Mary Jane Geiger, MD PhD FACP
Dr. Didier Saur, MD
Dr. Jonathan Goldman, MD FACC
For further inquiries please contact
Mark.Eberhardt@iconplc.com
