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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.

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Agenda

Panel

Mark B. McClellan

Former Brookings Expert

Mark McClellan is a senior fellow and director of the Health Care Innovation and Value Initiative at Brookings. He has written a number of publications on care delivery reform, physician payment reform, and accountable care implementation in the U.S. and abroad.

Sentinel's Progress: Past, Present, and Future

Mini Sentinel's Current Active Surveillance Capabilities

R

Rich Platt

Harvard Medical School and Harvard Pilgrim Health Care Institute

Stakeholder Roles in Sentinel

R

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

Remarks from the Director of FDA's Center for Drug Evaluation and Research

J

Janet Woodcock

Director, Center for Drug Evaluation and Research - US Food and Drug Administration

Closing Remarks and Adjournment

Mark B. McClellan

Former Brookings Expert

Mark McClellan is a senior fellow and director of the Health Care Innovation and Value Initiative at Brookings. He has written a number of publications on care delivery reform, physician payment reform, and accountable care implementation in the U.S. and abroad.

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