Brookings Roundtable on Active Medical Product Surveillance: Overview of FDA’s Sentinel Initiative

Event Information
Tuesday, September 6, 2011
Event Type

On September 7, the Engelberg Center hosted the first of the three-part Sentinel Initiative 101 Webinar Series, “Overview of FDA’s Sentinel Initiative” to review ongoing activities and accomplishments. The roundtable featured a presentation from Dr. Judy Racoosin, Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration.

Dr. Racoosin’s presentation provided a high-level review of the Sentinel Initiative’s scope and achievements including:

  • FDA’s 3-year vision for the Sentinel Initiative
  • A brief overview of the role of the Mini-Sentinel pilot, the Observational Medical Outcomes Partnership, the Federal Partners Collaboration, and the Brookings Institution cooperative agreement
  • Next steps for the Sentinel Initiative

Mark McClellan MD, PhD, MPA; Engelberg Center for Health Care Reform, Brookings Institution, Washington, DC


Judy Racoosin MD, MPH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Springs, MD