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Session 3: Drug Induced Liver Injury (DILI)
Session Chair(s)
Lesley Wise, PHD, MSC
Managing Director, Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom
Drug Induced Liver Injury is a potentially serious ADR. This session will provide an overview of the current research and assessment process for DILI from the president of CIOMS, pharmacology professor and hepatologist Professor Hervé Le-Louet.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand the main ways that drugs can cause DILI
- Understand the limitations of non-clinical and clinical research in predicting DILI
- Learn about the current research into DILI
Speaker(s)
Hervé Le Louet, DrMed, DRSC, MD, PHD, MS
President, CIOMS, Switzerland
Update from CIOMS on Current Developments in DILI
Arie Regev, MD
Vice President, Medical Global Patient Safety , Eli Lilly and Company , United States
Principles of Detection and Characterization of DILI
Mark Avigan, MD
Associate Director for Critical Path Initiatives, OPE, OSE, CDER, FDA, United States
DILI Risk Assessment and Risk Stratification in Clinical Trials and Post-Marketing