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San Diego Convention Center

Jun 15, 2014 8:30 AM - Jun 19, 2014 12:45 PM

111 W Harbor Drive, , San Diego, CA 92101 , USA

DIA 2014 50th Annual Meeting "Celebrate the Past - Invent the Future"

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Prediction of Safety: An Evolving Field for Selecting Low-Risk Compounds Towards an Effective Life Cycle of a Product

Session Chair(s)

Pradip Paul, MD, MS

Pradip Paul, MD, MS

Consultant

Strategic Pharmacovigilance and Risk Management, United States

Using Virtual Population Simulation to Generate Insights on Drug Performance in Special Populations

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)

Badri Rengarajan, MD

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

Mark Avigan, MD

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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