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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
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October 25
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Panel
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University -
Sentinel's Progress: Past, Present, and Future
MRMelissa Robb U.S. Food and Drug Administration -
Mini Sentinel's Current Active Surveillance Capabilities
RPRich Platt Harvard Medical School and Harvard Pilgrim Health Care Institute -
Stakeholder Roles in Sentinel
RSRachel Sherman Principal, Drug and Biological Drug Products - Greenleaf Health LLC -
Proposed Role of Medical Product Developers in the Execution of Safety Surveillance Activities
BMBriggs Morrison -
Proposal for Medical Product Developers to Support Safety Science Methods Research and Development
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Remarks from the Director of FDA's Center for Drug Evaluation and Research
JWJanet 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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