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The Engelberg Center for Health Care Reform at Brookings hosted a small expert workshop to discuss legal issues in the development and implementation of FDA’s Sentinel Initiative for medical product safety surveillance.
The one-day workshop featured productive discussion and exchange of ideas with panelists representing government, academia, and the private sector on topics including:
March 8, 2010
8:30 AM - 3:45 PM EST
Washington Marriott at Metro Center
Grand Ballroom
775 12th St. NW
Washington, DC
Map
Engelberg Center for Health Care Reform engelbergevents [at] brookings.edu (202) 797-4391
Welcome, Introduction, and Meeting Objectives
Mark B. McClellan
Director
Economic Studies
View Bio
The Sentinel Initiative
Rachel E. Behrman
Center for Drug Evaluation and Research, Food and Drug Administration
Panel 1: Scientific and Data Needs for Active Medical Product Surveillance in the Near and Longer Terms
Richard Platt
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute
Paul Stang
Johnson & Johnson and Observational Medical Outcomes Partnership
Judy Racoosin
Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration
Panel 2: Protecting Patient Privacy in Medical Product Safety Surveillance
Kristen B. Rosati
Coppersmith Schermer & Brockelman PLC
Deven McGraw
Health Privacy Project, Center for Democracy and Technology
Joy Pritts
Office of the National Coordinator for Health Information Technology, HHS
Donald O. Beers
Office of Chief Counsel, Food and Drug Administration
Panel 3: Appropriate Human-Subject Protections for Research Use of Sentinel System Data
Barbara Evans
Health Law & Policy Institute and Center for Biotechnology & Law, University of Houston
Jerry Menikoff
Office for Human Research Protections, HHS
Kenneth W. Goodman
University of Miami Bioethics Program
Laura Youngblood
National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention
Kate Cook
Office of the Center Director, Center for Biologics Evaluation and Research, Food and Drug Administration
Panel 4: Addressing Legal Liability in Medical Product Safety Surveillance
Stanley Watson
Kaiser Foundation Research Institute
Heidi Garwood
Humana
Dan Troy
GlaxoSmithKline
Recap and Closing Remarks
May 23, 2012
Blog Post
May 22, 2012, George L. Perry
Opinion
May 22, 2012, Gary Burtless
Paper
May 20, 2012, Martin Neil Baily and Bruce Katz
May 17, 2012, Ted Gayer and Phillip Swagel
May 17, 2012, Tracy Gordon
Testimony
May 16, 2012, Douglas J. Elliott
May 15, 2012, George L. Perry
Economic Studies ›
Report
October 2010, Joseph Antos, PhD, John Bertko, Michael Chernew, PhD, David Cutler, PhD, Francois de Brantes, Dana Goldman, PhD, Bob Kocher, Mark B. McClellan, Elizabeth McGlynn, PhD, Mark Pauly, PhD, Leonard Schaeffer and Stephen Shortell, PhD
February 8, 2012, Allan A. Friedman and Darrell M. West