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McCormick Place

Jun 18, 2017 8:30 AM - Jun 22, 2017 12:45 PM

2301 South Martin Luther King Jr. Drive, Gate 4, Chicago, IL 60616

DIA 2017 Annual Meeting

IMEDS: A Public-Private Partnership to Facilitate Real World Evidence Generation Based on the FDA's Sentinel System

Session Chair(s)

June  Wasser, MA

June Wasser, MA

Executive Director, Reagan-Udall Foundation For the FDA, United States

The Reagan-Udall Foundation for the FDA will introduce the IMEDS program to facilitate engagement with industry and other researchers to utilize the same tools and methods developed for the FDA's Sentinel System. IMEDS provides the opportunity to leverage expertise and standardized processes for the rapid and robust analysis of regulated products in a post-market setting. The panel will discuss the IMEDS process, characteristics of the IMEDS system as well as an overview of the IMEDS experience.

Learning Objective : Demonstrate a robust understanding of IMEDS, its capabilities, and characteristics; Discuss broad-use cases as well as potential enhancements to IMEDS

Speaker(s)

David  Martin, MD, MPH

Overview of the IMEDS Program

Vice President, Head, PCO Center of Excellence, Novartis, United States

Robert  Reynolds, DRSC, MSC, FISPE

Panelist

Vice President, Epidemiology, Worldwide Regulatory and Safety, Pfizer Inc, United States

Kevin  Haynes, PHARMD

Panelist

Director of Clinical Epidemiology, HealthCore Inc., United States

Jeffrey  Brown, PHD, MA

Panelist

Associate Professor, Department of Population Medicine, Harvard Pilgrim Health Care Institute/Harvard Medical School, United States

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