Brookings Roundtable on Active Medical Product Surveillance

Friday, October 30, 2009

11:00 am - 12:00 pm EDT

The Brookings Institution

Teleconference Call

1775 Massachusetts Ave., NW
Washington, DC

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

October 30
- Welcome and Introduction
  
  Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
- Update on FDA Active Surveillance Efforts
  
  JR
  
  Judy Racoosin Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research
  
  JS
  
  Judy Staffa Associate Director for Regulatory Research, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA
  
  BB
  
  Bob Ball Medical Officer IV, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA
  
  TS
  
  Tom Scarnecchia Executive Director, Observational Medical Outcomes Partnership, FNIH
- Roundtable Discussion and Questions
  
  Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
- Wrap-Up and Next Steps
  
  Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University