Past Event

Brookings Active Surveillance Implementation Council Meeting #1

During the first BASIC meeting, Council members received updates on several ongoing pilot activities including the Observational Medical Outcomes Partnership (OMOP), Mini-Sentinel, the Exploring and Understanding Adverse Drug Reactions (EU-ADR) Project, and the Vaccine Safety Datalink.

Recognizing similarities among these pilot activities, the Council considered potential opportunities for sharing findings and minimizing overlap. Following a presentation by McKinsey & Company on lessons learned from public-private partnerships and complex alliances in other industries, the Council discussed governance of the Sentinel System. Specifically, Council members explored the merits of potential organizational models focusing on governance for multiple users and multiple uses, economic sustainability, and ensuring participation of appropriate stakeholders.

Agenda

Welcome, Introduction, Charge to the Council, and Meeting Objectives

Remarks from FDA Leadership

D

Janet Woodcock

Director, Center for Drug Evaluation and Research - US Food and Drug Administration

D

Rachel Behrman

Director, Office of Medical Policy, Center for Drug Evaluation and Research

Session I: U.S.-Based Medical Product Active Surveillance Pilot Projects

J

Paul Stang

Johnson & Johnson and the Observational Medical Outcomes Partnership

S

Judy Racoosin

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

C

Francesca Cunningham

Center for Medication Safety PSCI, Department of Veterans Affairs National Center for Patient Safety and Pharmacy Benefits Management Services

P

Trinka Coster

Pharmacovigilance Center, United States Army, Office of the Surgeon General

P

Richard Platt

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

Council Discussion

Session II: Other Initiatives That Can Inform Development of the Sentinel System

D

Miriam Sturkenboom

Department of Medical Informatics and Epidemiology, Erasmus University Medical Center

O

Chesley Richards

Office of Prevention through Healthcare, Office of the Director for Policy, Centers for Disease Control and Prevention

C

Jean Slutsky

Center for Outcomes and Evidence, Agency for Healthcare Research and Quality

Session III: Organization Models for the Sentinel System

W

Alec Walker

World Health Information Science Consultants, LLC

Discussion Summary and Next Steps

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