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
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January 18
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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 UniversityRichard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care InstituteRobert 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 UniversityRhonda Medows UnitedHealthcareJohn Santa Consumer Reports Health Ratings CenterMyrl Weinberg Chief Executive Officer - National Health CouncilElliott Levy Bristol-Myers SquibbEd Staffa U.S. Food and Drug Administration -
Final Remarks
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
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