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Session 7 – Benefit-Risk and Risk Management

Track:
General Session

Day & Time:
January 14, 1:30PM - 3:00PM

Type:
Session

Title:
Session 7 – Benefit-Risk and Risk Management

Chair(s):
Michael Richardson, MD,FFPM
International Head GPV&E and EU QPPV
Bristol-Myers Squibb, United Kingdom

William W. Gregory, PhD
Senior Director, Worldwide Safety and Regulatory
Pfizer Inc, United States

Description:
Session 7 – Benefit-Risk and Risk Management

Presentation(s) & Speaker(s):
Benefit-Risk: Interface with Risk Management
Susan Welsh
Vice President, Medical Safety
Bristol Myers Squibb, Co., United States

Benefit-Risk Work Streams: Quantitative vs. Qualitative
Rebecca A. Noel, DrPH,MPH
Senior Research Scientist, Global Patient Safety
Eli Lilly and Company, United States

Benefit-Risk from a Regulator's Perspective
Sara L. Eggers
Operations Research Analyst, Office of Program and Strategic Analysis, CDER
FDA, United States