Past Event

Brookings Roundtable on Active Medical Product Surveillance

This event was the first of a new series of roundtable teleconferences on active medical product surveillance – providing a forum to discuss public and private initiatives in which methods, data sources, and technology related to active medical product surveillance are being developed.

The call featured an update from FDA leaders on their active surveillance activities, as well as a moderated question and answer period following the FDA’s presentations.

Convened by the Engelberg Center for Health Care Reform at Brookings and suppored by a grant from the Food and Drug Administration.

Agenda

Welcome and Introduction

Update on FDA Active Surveillance Efforts

S

Judy Racoosin

Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research

A

Judy Staffa

Associate Director for Regulatory Research, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA

M

Bob Ball

Medical Officer IV, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA

E

Tom Scarnecchia

Executive Director, Observational Medical Outcomes Partnership, FNIH

Roundtable Discussion and Questions

Wrap-Up and Next Steps

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