Past Event

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

Remarks from the Office of the Commissioner

Current Status of and Future Challenges in Active Surveillance

D

Janet Woodcock

Director, Center for Drug Evaluation and Research - US Food and Drug Administration

P

Rachel Sherman

Principal, Drug and Biological Drug Products - Greenleaf Health LLC

Brief Overview of Mini-Sentinel

P

Richard Platt

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

Brief Overview of the Observational Medical Outcomes Partnership

J

Paul Stang

Johnson & Johnson and the Observational Medical Outcomes Partnership

Medical Product Developer's Perspectives in Post-Market Medical Product Surveillance

Moderated Discussion

Medical Product Developer Roles in Improving Methods for Post-Market Medical Product Surveillance

Closing Remarks

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