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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
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