Sentinel Initiative Public Workshop - Fifth Annual

Project Title Sentinel Initiative Public Workshop - Fifth Annual
Date
Thursday, January 31, 2013
Description

On January 31, the Engelberg Center for Health Care Reform hosted the fifth annual Sentinel Initiative public workshop, at the Washington Marriott Wardman Park in Washington, DC. This public workshop brought together the members of various stakeholder communities for a productive discussion on the continuing development of active medical product surveillance, including:

  • The State of Mini-Sentinel Activities
  • Selected Mini-Sentinel Protocol-Driven Evaluations
  • Collaborations Supporting Active Surveillance Research
  • Planned Expansion of Prospective Surveillance Programs
  • Opportunities to Expand the Public Health Impact of the Sentinel Initiative
  • Stakeholder Feedback on Mini-Sentinel as a Tool for Evaluating Drug Safety Issues that Require Regulatory Action

Dr. Janet Woodcock, the Director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, provided the morning keynote address. Both Dr. Woodcock and Dr. Karen Midthun, the Director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration participated in a panel seeking input on the ongoing progress as well as the future of the Sentinel Initiative.

Host

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

Location
Presenters

Janet Woodcock MD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

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

Marsha Reichman PhD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

Karen Midthun MD; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD

Michael Nguyen MD; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD

Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Healthcare Institute and Harvard Medical School, Boston, MA

Melissa Butler PharmD, PhD, MPH, BCPS; Kaiser Permanente Southeast, Atlanta, GA;

Katherine Yih PhD, MPH; Department of Population Medicine, Harvard Pilgrim Healthcare Institute and Harvard Medical School, Boston, MA

Jennifer Nelson PhD; Group Health institute, Seattle, Washington

David Madigan PhD; Columbia University, New York, NY

Patrick Archdeacon MD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

Elizabeth Chrischilles MS, PhD; Department of Epidemiology, University of Iowa College of Public Health, Iowa City, IA

Sebastian Schneeweiss MD, ScD; Department of Medicine, Brigham and Women’s Hospital, Boston, MA