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Report of CIOMS DILI Working Group
Session Chair(s)
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
Associate Director for Critical Path Initiatives, OPE, OSE, CDER, FDA, United States
Introduction to the CIOMS Working Group
Hervé Le Louet, DrMed, DRSc, MD, PhD, MS
President, CIOMS, Switzerland
Goals, Initiatives, and Context of the 2020 DILI Report
Arie Regev, MD
Vice President, Medical Global Patient Safety , Eli Lilly and Company , United States
Principles in the Detection, Characterization, and Risk Assessment of DILI in Clinical Trials
Robert J. Fontana, MD
Professor of Medicine, University of Michigan, United States
Steps Towards the Identification and Utilization of Liver Safety Biomarkers
Walter Straus, DrMed, MD, MPH, FACP
Vice President, Safety and PV, Moderna, United States
Best Practices in Postmarket DILI Risk Assessment, Risk Minimization, and Communication
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