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
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May 31
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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 AdministrationRachel Sherman Principal, Drug and Biological Drug Products - Greenleaf Health LLCDonald 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
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Moderated Discussion
Myrl Weinberg Chief Executive Officer - National Health CouncilStanley B. Watson Kaiser Foundation Research InstituteGregory W. Daniel Former Brookings Expert, HealthCoreRobert 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 BioethicsElliott Levy Bristol-Myers SquibbAlexander M. Walker World Health Information Science Consultants, LLCGarry Neil Johnson & Johnson -
Closing Remarks
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
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