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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

Report of CIOMS DILI Working Group

Session Chair(s)

Mark  Avigan, MD

Mark Avigan, MD

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

FDA, United States

This session will discuss the principles in the detection, characterization and risk assessment of DILI in clinical trials and post-marketing, liver safety biomarkers and DILI risk stratification, risk minimization measures and risk communication.

Learning Objective : Describe the accurate identification, assessment, and management of DILI risk; Discuss a new initiative to tackle this problem undertaken by an international working group of industry, academic, and regulatory experts; Examine the findings by CIOMS for best practices in DILI risk assessment and& management and biomarker development in clinical trials and the post-market.

Speaker(s)

Mark  Avigan, MD

Introduction to the CIOMS Working Group

Mark Avigan, MD

FDA, United States

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

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

Goals, Initiatives, and Context of the 2020 DILI Report

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

CIOMS, Switzerland

President

Arie  Regev, MD

Principles in the Detection, Characterization, and Risk Assessment of DILI in Clinical Trials

Arie Regev, MD

Eli Lilly and Company , United States

Chair, Liver and GI Safety Committee

Robert J. Fontana, MD

Steps Towards the Identification and Utilization of Liver Safety Biomarkers

Robert J. Fontana, MD

University of Michigan, United States

Professor of Medicine

Walter  Straus, DrMed, MD, MPH, FACP

Best Practices in Postmarket DILI Risk Assessment, Risk Minimization, and Communication

Walter Straus, DrMed, MD, MPH, FACP

Moderna, United States

Vice President, Safety and PV

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