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Pharmacovigilance and Risk Management Strategies Conference

Session 3: Drug Induced Liver Injury (DILI)

Session Chair(s)

Lesley  Wise, PhD, MSc

Lesley Wise, PhD, MSc

  • Managing Director
  • Wise PV&RM 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


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

Update from CIOMS on Current Developments in DILI

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

  • President, Head of PV Coordination
  • CIOMS and APHP, France
Arie  Regev, MD

Principles of Detection and Characterization of DILI

Arie Regev, MD

  • Chair, Liver and GI Safety Committee
  • Eli Lilly and Company , United States
Mark I. Avigan, MD

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

Mark I. Avigan, MD

  • Associate Director, Office of Pharmacovigilance and Epidemiology, OPE, CDER
  • FDA, United States