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The Engelberg Center for Health Care Reform at Brookings hosted a small expert workshop to discuss legal issues in the development and implementation of FDA’s Sentinel Initiative for medical product safety surveillance.
The one-day workshop featured productive discussion and exchange of ideas with panelists representing government, academia, and the private sector on topics including:
- Protecting patient privacy in medical product safety surveillance;
- Appropriate human-subject protections for research use of Sentinel System data; and
- Addressing legal liability in medical product safety surveillance.
Agenda
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March 8
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Welcome, Introduction, and Meeting Objectives
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University -
The Sentinel Initiative
RBRachel Behrman Director, Office of Medical Policy, Center for Drug Evaluation and Research -
Panel 1: Scientific and Data Needs for Active Medical Product Surveillance in the Near and Longer Terms
RPRichard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care InstitutePSPaul Stang Johnson & Johnson and the Observational Medical Outcomes PartnershipJRJudy Racoosin Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research -
Panel 2: Protecting Patient Privacy in Medical Product Safety Surveillance
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Panel 3: Appropriate Human-Subject Protections for Research Use of Sentinel System Data
BEBarbara Evans Health Law & Policy Institute and Center for Biotechnology & Law, University of HoustonJMJerry Menikoff Office for Human Research Protections, HHSKWGKenneth W. Goodman University of Miami Bioethics ProgramLYLaura Youngblood National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and PreventionKCKate Cook Office of the Center Director, Center for Biologics Evaluation and Research, Food and Drug Administration -
Panel 4: Addressing Legal Liability in Medical Product Safety Surveillance
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Recap and Closing Remarks
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
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