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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)
Amy Freedman, MD, MPH
Therapeutic Area Safety Head, Cardiovascular Metabolism, Janssen Pharmaceutical Companies of Johnson & Johnson, United States
Anticipated Events Safety Monitoring Plan (ASMP)
Barbara Hendrickson, DrMed, MD
Clinical Associate, Pediatric Infectious Diseases, University of Chicago, United States
Safety Assessment Committee (SAC) Pilot
Robert J. Temple, MD
Senior Advisor for Clinical Science, OCD and Immediate Office, OND, CDER, FDA, United States
Discussant
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