Understanding and Discussing the Implications of the FDA’s Sentinel Initiative

Project Title Understanding and Discussing the Implications of the FDA’s Sentinel Initiative
Date
Tuesday, October 25, 2011
Description

On October 25, the Engelberg Center hosted and expert workshop, “Understanding and Discussing the Implications of FDA’s Sentinel Initiative,” which focused on issues of importance for medical product developers.

This meeting brought together representatives to discuss the role of FDA’s pilot program, Mini-Sentinel, within FDA’s broader array of tools to monitor medical product safety and to discuss mechanisms for how developers could support and engage with FDA on Sentinel-related activities.

Host

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

Location
Presenters

Janet Woodcock MD; U.S. Food and Drug Administration, Silver Spring, MD

Rachel Sherman MD, MPH, FACP; U.S. Food and Drug Administration, Silver Spring, MD

Melissa Robb RN; U.S. Food and Drug Administration, Silver Spring, MD

Richard Platt MD, MSc; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA