Fourth Annual Sentinel Initiative Public Workshop
The Engelberg Center for Health Care Reform at Brookings hosted the Fourth Annual Sentinel Initiative Public Workshop on Wednesday, January 18, at the Washington Marriott in Washington, DC. This public workshop brought together the stakeholder community for a productive discussion on a variety of topics in active medical product surveillance, including an update on the U.S. Food and Drug Administration’s (FDA’s) Sentinel Initiative; efforts to support the advancement of safety science; and stakeholder perspectives on the Sentinel Initiative’s progress and future direction.
Dr. Stephen Spielberg, the FDA’s newly appointed Deputy Commissioner for Medical Products and Tobacco, provided the morning keynote address.
Agenda
Welcome and Overview
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Keynote Address
Stephen Spielberg
U.S. Food and Drug Administration
Overview of the Sentinel Initiative: FDA’s Perspective
Rachel Sherman
Principal, Drug and Biological Drug Products - Greenleaf Health LLC
Update on Mini-Sentinel Activities: One Tool to Promote Drug Safety
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Robert Temple
Deputy Director for Clinical Science, Center for Drug Evaluation and Research - U.S. Food and Drug Administration
Stakeholder Panel Discussion: Managing Expectations and Communicating Findings from Sentinel
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Rhonda Medows
UnitedHealthcare
John Santa
Consumer Reports Health Ratings Center
Myrl Weinberg
Chief Executive Officer - National Health Council
Elliott Levy
Bristol-Myers Squibb
Ed Staffa
U.S. Food and Drug Administration
Final Remarks
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
More Information
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