Pharmacovigilance and Risk Management Strategies Conference

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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)

Update from CIOMS on Current Developments in DILI

Hervé Le Louet, DrMed, DrSc, MD, PhD, MS

CIOMS, Switzerland

President

Principles of Detection and Characterization of DILI

Arie Regev, MD

Eli Lilly and Company , United States

Vice President, Medical Global Patient Safety

DILI Risk Assessment and Risk Stratification in Clinical Trials and Post-Marketing

Mark Avigan, MD

FDA, United States

Associate Director for Critical Path Initiatives, OPE, OSE, CDER