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Session 6 - Drug-Induced Liver Injury (DILI) in Clinical Trials and Post Marketing
Session Chair(s)
Paul B Watkins, MD
Professor; Director, Hamner-UNC Inst for Drug Safety Sciences
University of North Carolina At Chapel Hill, United States
DILI remains one of the most frequent injuries that result in termination of clinical development programs, and regulatory actions on drugs post-approval. The costs and other consequences of discovering significant liver safety concerns rises exponentially at each successive stage in clinical development. It is therefore essential to detect and interpret liver safety signals as early as possible during clinical development. This session will cover current approaches to collecting, managing and interpreting liver safety data at each stage in the clinical life of a new drug candidate. This session will end with a panel discussion.
Speaker(s)
Using Data from Controlled Clinical Trials to Evaluate the Risk of Serious Liver Injury and Dysfunction
John R. Senior, MD
FDA, United States
Associate Director for Science, Office of Surveillance and Epidemiology, CDER
Detecting, Assessing, and Reporting DILI for Approved and Marketed Drugs
Mark Avigan, MD
FDA, United States
Associate Director for Critical Path Initiatives, OPE, OSE, CDER
The Future
Paul B Watkins, MD
University of North Carolina At Chapel Hill, United States
Professor; Director, Hamner-UNC Inst for Drug Safety Sciences
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