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Past Event

Distributed Data Networks for Active Medical Product Surveillance

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.

Agenda

Welcome, Introduction and Meeting Objectives

Mark B. McClellan

Former Brookings Expert

Director, Margolis Center for Health Policy - Duke University

FDA Perspective on Distributed Networks for Active Surveillance

J

Judy Racoosin

Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research

Experience with HMO Research Network

Experience with Vaccine Safety Datalink

J

James Baggs

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

Experience with DARTNet

W

Wilson Pace

Professor of Family Medicine, University of Colorado Health Sciences Center

Experience with EU-ADR

M

Miriam Sturkenboom

Department of Medical Informatics and Epidemiology, Erasmus University Medical Center

Experience with Observational Medical Outcomes Partnership

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

E

Elizabeth Andrews

Vice President of Pharmacoepidemiology and Risk Management, RTI Health Solutions

K

Ken Mandl

Associate Professor, Harvard Medical School

V

Vik Kheterpal

President and Chief Executive Officer, CareEvolution

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

M

Mary Durham

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

J

Jonathan Perlin

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

J

Janet Wright

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

Recap and Closing Remarks

Mark B. McClellan

Former Brookings Expert

Director, Margolis Center for Health Policy - Duke University

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