Past Event
Understanding and Discussing the Implications of FDA’s Sentinel Initiative
On October 25, the Engelberg Center hosted and expert workshop, “Understanding and Discussing the Implications of FDA’s Sentinel Initiative,” which focused on issues of importance for medical product developers.
This meeting brought together representatives to discuss the role of FDA’s pilot program, Mini-Sentinel, within FDA’s broader array of tools to monitor medical product safety and to discuss mechanisms for how developers could support and engage with FDA on Sentinel-related activities.
Agenda
Panel
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Sentinel's Progress: Past, Present, and Future
Melissa Robb
U.S. Food and Drug Administration
Mini Sentinel's Current Active Surveillance Capabilities
Rich Platt
Harvard Medical School and Harvard Pilgrim Health Care Institute
Stakeholder Roles in Sentinel
Rachel Sherman
Principal, Drug and Biological Drug Products - Greenleaf Health LLC
Proposed Role of Medical Product Developers in the Execution of Safety Surveillance Activities
Proposal for Medical Product Developers to Support Safety Science Methods Research and Development
Elliott Levy
Bristol-Myers Squibb
Garry Neil
Johnson & Johnson
Remarks from the Director of FDA's Center for Drug Evaluation and Research
Janet Woodcock
Director, Center for Drug Evaluation and Research - US Food and Drug Administration
Closing Remarks and Adjournment
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
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