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Session Chair(s)
Pradip Paul, MD, MS
Consultant
Strategic Pharmacovigilance and Risk Management, United States
Learning Objective : Discuss the recent technical advancements in predicting safety of a compound under development; Judge the level of a possible safety risk in late-stage development or after marketing; Utilize strategic planning in selecting an ideal candidate in drug development with low safety risk.
Speaker(s)
Using Virtual Population Simulation to Generate Insights on Drug Performance in Special Populations
Badri Rengarajan, MD
Jazz Pharmaceuticals, United States
Life Sciences
Stevens Johnson Syndrome: Mechanistic Insights
Keith K. Burkhart, MD
FDA, United States
Senior Advisor for Medical Toxicology, DARS, OCP, OTS
Prediction of Drug Induced Liver Injury (DILI)
Mark Avigan, MD
FDA, United States
Associate Director for Critical Path Initiatives, OPE, OSE, CDER
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