Expert Workshop: Patient and Consumer Engagement in FDA’s Sentinel Initiative
The U.S. Food and Drug Administration’s Sentinel Initiative has made important strides towards developing a valuable tool that can actively monitor the safety of medical products. Productive and broad collaboration among stakeholders from public and private institutions has been instrumental to this success. Since the Initiative’s inception, patient and consumer organizations have provided valuable perspectives and input into Sentinel.
On March 1, the Engelberg Center hosted an expert workshop, “Patients and Consumer Engagement in FDA’s Sentinel Initiative,” to explore opportunities for further engagement of these stakeholders in the Sentinel Initiative. This meeting brought together representatives from patient and consumer advocacy organizations and FDA to do the following:
- Provide patients and consumers with an overview of the Sentinel Initiative;
- Discuss opportunities for further patient and consumer engagement; and
- Discuss concrete next steps for evolving patient and consumer engagement.
Agenda
Welcome and Overview
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Sentinel: Past, Present, and Future
Rachel Sherman
Principal, Drug and Biological Drug Products - Greenleaf Health LLC
Overview of the Mini-Sentinel Pilot
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Moderated Question and Answer
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Facilitating Patient and Consumer Engagement
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Bray Patrick-Lake
Director of Patient Engagement - Duke Clinical and Translational Science Award
Myrl Weinberg
Chief Executive Officer - National Health Council
Diana Zuckerman
National Research Center for Women & Families/Cancer Prevention and Treatment Fund
James Valentine
U.S. Food and Drug Administration
Furthering Initiatives for Patient and Consumer Engagement
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Rachel Sherman
Principal, Drug and Biological Drug Products - Greenleaf Health LLC
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Bray Patrick-Lake
Director of Patient Engagement - Duke Clinical and Translational Science Award
Lawrence Bachorik
U.S. Food and Drug Administration
Closing Remarks and Adjournment
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
More Information
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