Past Event
Expert Workshop: Setting Priorities for Methods Research and Development for Active Medical Product Surveillance
On June 3, the Engelberg Center hosted an expert workshop on setting priorities for methods research and development for active medical product surveillance.
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
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
Janet Woodcock
Director, Center for Drug Evaluation and Research - US Food and Drug Administration
Methods Research and Development: Lessons Learned, Current Activities, and Existing Gaps
Judy Racoosin
Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research
David Madigan
Columbia University
Sebastian Schneeweiss
Harvard Medical School and Brigham and Women’s Hospital
Jennifer Clark Nelson
Group Health Research Institute
Moderated Discussion
Susan Ellenberg
University of Pennsylvania
Jeffrey A. Kelman
Centers for Medicare & Medicaid Services
Alexander M. Walker
World Health Information Science Consultants, LLC
Robert Ball
Deputy Director of the Office of Surveillance and Epidemiology - U.S. Food and Drug Administration
Robert O’Neill
U.S. Food and Drug Administration
Developing an Agenda to Advance Methods Research and Development
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Paul Stang
Johnson & Johnson and the Observational Medical Outcomes Partnership
Moderated Discussion
Susan Ellenberg
University of Pennsylvania
Jeffrey A. Kelman
Centers for Medicare & Medicaid Services
Alexander M. Walker
World Health Information Science Consultants, LLC
Robert Ball
Deputy Director of the Office of Surveillance and Epidemiology - U.S. Food and Drug Administration
Robert 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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