Brookings Active Surveillance Implementation Council Meeting #3
On June 1, the Engelberg Center hosted the third Brookings Active Surveillance Implementation Council meeting, with Council members gathering to discuss the role of medical product developers in active medical product surveillance and specifically their role in improving methods.
Discussion focused on medical product developer’s perspectives, including what role developers want to play in active surveillance and possible approaches for achieving such roles. In addition, participants discussed the role OMOP, Mini-Sentinel, and other federal initiatives have played in addressing developer concerns around methods for active surveillance, as well as types of organizational models that could support a long-term strategy for methods research and development.
Agenda
Welcome, Introduction, and Meeting Objectives
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Remarks from the Office of the Commissioner
John Taylor III
Office of the Commissioner
Current Status of and Future Challenges in Active Surveillance
Janet Woodcock
Director, Center for Drug Evaluation and Research - US Food and Drug Administration
Rachel Sherman
Principal, Drug and Biological Drug Products - Greenleaf Health LLC
Donald O. Beers
Office of Chief Counsel
Brief Overview of Mini-Sentinel
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Brief Overview of the Observational Medical Outcomes Partnership
Paul Stang
Johnson & Johnson and the Observational Medical Outcomes Partnership
Medical Product Developer's Perspectives in Post-Market Medical Product Surveillance
Moderated Discussion
Myrl Weinberg
Chief Executive Officer - National Health Council
Stanley B. Watson
Kaiser Foundation Research Institute
Robert M. Califf
Duke Translational Medicine Institute
Medical Product Developer Roles in Improving Methods for Post-Market Medical Product Surveillance
Ronald Lee Krall
University of Pennsylvania Center for Bioethics
Elliott Levy
Bristol-Myers Squibb
Alexander M. Walker
World Health Information Science Consultants, LLC
Garry Neil
Johnson & Johnson
Closing Remarks
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
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