Nov 23

Past Event

Distributed Data Networks for Active Medical Product Surveillance

Event Materials

Summary

An expert technical workshop was convened to discuss distributed data networks and their use in active medical product surveillance.

This one-day technical workshop identified key features of existing data networks conducting medical product safety surveillance; discussed data infrastructure needs for a future national active surveillance system; and discussed barriers and explored solutions to private data environment participation in active surveillance. The overarching goal of the meeting was to stimulate productive discussion and exchange of ideas on these topics.

Convened by the Engelberg Center for Health Care Reform at Brookings and supported by a grant from the Food and Drug Administration.

Details

November 23, 2009

8:30 AM - 3:30 PM EST

The Brookings Institution

Stein Room

1775 Massachusetts Avenue, N.W.

Map

For More Information

Engelberg Center for Health Care Reform

(202) 797-6000

Event Agenda

  • Welcome, Introduction and Meeting Objectives

    • mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies

  • FDA Perspective on Distributed Networks for Active Surveillance

    • Judy Racoosin

      Sentinel Initiative Scientific Lead, Office of Critical Path Programs, Office of the Commissioner, FDA

  • Experience with HMO Research Network

    • Jeff Brown

      Lecturer on Population Medicine, Harvard Pilgrim Health Care

  • Experience with Vaccine Safety Datalink

    • James Baggs

      Immunization Safety Office, National Center for Preparedness, Detection, and Control of Infectious Diseases, CDC

  • Experience with DARTNet

    • Wilson Pace

      Professor of Family Medicine, University of Colorado Health Sciences Center

  • Experience with EU-ADR

    • Miriam Sturkenboom

      Professor of Pharmacoepidemiology, Erasmus University Medical Center, the Netherlands

  • Experience with Observational Medical Outcomes Partnership

    • Patrick Ryan

      Manager, Drug Development Sciences, GlaxoSmithKline Research and Development

  • Response Panel: What Data Infrastructure Will Achieve the Needs for Active Surveillance in the Near and Longer Terms?

    • Elizabeth Andrews

      Vice President of Pharmacoepidemiology and Risk Management, RTI Health Solutions

    • Ken Mandl

      Associate Professor, Harvard Medical School

      Director of the Intelligent Health Laboratory, Children's Hospital Informatics Program

    • Vik Kheterpal

      Principal, CareEvolution, Inc.

  • Panel II: Barriers and Solutions to Private Sector Participation in Active Surveillance Networks

    • Mary Durham

      Senior Investigator, Director, Center for Health Research, Vice President for Research, Kaiser Foundation Hospitals

    • Jonathan Perlin

      Chief Medical Officer and President, Clinical Services, Hospital Corporation of America

    • Terri Madison

      President, i3 Drug Safety

    • Janet Wright

      Senior Vice President for Science and Quality, American College of Cardiology

    • Marcus D. Wilson

      President, HealthCore

  • Recap and Closing Remarks

    • mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies