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FDA Expectations On Drug-Induced Liver Injury (DILI) And An Approach To Detecting And Monitoring

January 10, 2011

ICONuary, 2011
Location: Webinar

FDA expectations on Drug-Induced Liver Injury (DILI) and Liver are having an important impact on the pharmaceutical industry in assessing the potential for a drug to cause severe liver injury.

This webinar will discuss hepatic drug toxicity, FDA's guidance on DILI and demonstrate an approach that specifically targets real time identification of abnormal hepatic triggers and subsequent medical monitoring of patients.

Topics to be covered:

  • FDA Guidance and DILI: Key Implications
  • Diagnosis of Drug Induced Liver Injury
  • What is HY's Law?
  • Monitoring and pre-existent liver disease
  • How to detect DILI in real-time
  • How to manage a potential DILI case

Who should attend
Professionals in Drug Development, Regulatory Affairs, Medical, Clinical Safety/Pharmacovigilance

Expert Panalists

Suzanne Gagnon, M.D.
Chief Medical Officer
ICON Clinical Research

Steven Schenker, MD
Emeritus Professor of Medicine
University of Texas Science Health Science Center
San Antonio, Texas

Gareth Milborrow, MBBCh
Senior Clinical Research Physician
ICON Clinical Research

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