Pharmaceutical & Drug Policy
Comments on Medicare Drug Price Negotiation Program’s Section 30.2 and Part B high spend drugs
On June 3, the Engelberg Center hosted an expert workshop on setting priorities for methods research and development for active medical product surveillance.
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This technical workshop focused on topics including lessons learned, current activities, and anticipated needs for methods research and development. Presentations from a wide range of key stakeholders – including representatives from the U.S. Food and Drug Administration, the Observational Medical Outcomes Partnership, and Mini-Sentinel – aimed to develop a practical agenda for advancing this work.
Agenda
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June 2
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Welcome, Overview, and Meeting Objectives
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University -
FDA's Perspective on the Current Status and Future of Active Medical Product Surveillance and Safety Science
JWJanet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug Administration -
Methods Research and Development: Lessons Learned, Current Activities, and Existing Gaps
JRJudy Racoosin Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and ResearchPRPatrick RyanDMDavid Madigan Columbia UniversitySSSebastian Schneeweiss Harvard Medical School and Brigham and Women’s HospitalJCNJennifer Clark Nelson Group Health Research Institute -
Moderated Discussion
SESusan Ellenberg University of PennsylvaniaJAKJeffrey A. Kelman Centers for Medicare & Medicaid ServicesAMWAlexander M. Walker World Health Information Science Consultants, LLCRBRobert Ball Deputy Director of the Office of Surveillance and Epidemiology - U.S. Food and Drug AdministrationRORobert O’Neill U.S. Food and Drug Administration -
Developing an Agenda to Advance Methods Research and Development
RPRichard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care InstitutePSPaul Stang Johnson & Johnson and the Observational Medical Outcomes Partnership -
Moderated Discussion
SESusan Ellenberg University of PennsylvaniaJAKJeffrey A. Kelman Centers for Medicare & Medicaid ServicesAMWAlexander M. Walker World Health Information Science Consultants, LLCRBRobert Ball Deputy Director of the Office of Surveillance and Epidemiology - U.S. Food and Drug AdministrationRORobert O’Neill U.S. Food and Drug Administration -
Closing Remarks
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
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