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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
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March 1
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Welcome and Overview
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University -
Sentinel: Past, Present, and Future
RSRachel Sherman Principal, Drug and Biological Drug Products - Greenleaf Health LLC -
Overview of the Mini-Sentinel Pilot
RPRichard 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 UniversityBPBray Patrick-Lake Director of Patient Engagement - Duke Clinical and Translational Science AwardMWMyrl Weinberg Chief Executive Officer - National Health CouncilDZDiana Zuckerman National Research Center for Women & Families/Cancer Prevention and Treatment FundLMLisa McGiffertJVJames 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 UniversityRSRachel Sherman Principal, Drug and Biological Drug Products - Greenleaf Health LLCRPRichard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care InstituteBPBray Patrick-Lake Director of Patient Engagement - Duke Clinical and Translational Science AwardLBLawrence 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
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