DIA 2021 Global Annual Meeting

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The Spirit of the IND Safety Reporting Final Rule

Session Chair(s)

Greg Ball, PhD

Safety Data Scientist

ASAPprocess, United States

This session will emphasize the importance of having a thoughtful process; a system in place to look for clinically important imbalances, applying the best clinical and quantitative judgment, while maintaining trial integrity.

Learning Objective : Discuss how to leverage the scientific expertise and medical judgment of sponsor safety teams with 1) a multidisciplinary approach, 2) quantitative frameworks for measuring evidence of association, 3) assessments customized for the specific product, and 4) decisions that incorporate medical judgment.

Speaker(s)

Anticipated Events Safety Monitoring Plan (ASMP)

Amy Freedman, MD, MPH

Janssen Pharmaceutical Companies of Johnson & Johnson, United States

Therapeutic Area Safety Head, Cardiovascular Metabolism

Safety Assessment Committee (SAC) Pilot

Barbara Hendrickson, DrMed, MD

University of Chicago, United States

Clinical Associate, Pediatric Infectious Diseases

Discussant

Robert J. Temple, MD

FDA, United States

Senior Advisor for Clinical Science, OCD and Immediate Office, OND, CDER

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