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Hilton Baltimore Inner Harbor

Jan 27, 2025 7:30 AM - Jan 29, 2025 12:45 PM

401 W Pratt Street, Baltimore, MD 21201, USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!

Advance Rates End

DAYS

HOURS

MINUTES

SECONDS

Session 9: Advancing Hepatic Safety: Innovations in Predicting, Assessing, and Managing Drug-Induced Liver Toxicity

Session Chair(s)

Barbara  Hendrickson, DrMed, MD

Barbara Hendrickson, DrMed, MD

Clinical Associate, Pediatric Infectious Diseases

University of Chicago, United States

Hepatotoxicity is a leading cause of drug development discontinuation as well as drug withdrawal from the market due to safety reasons. Consequently, the prediction, assessment and management of potential drug induced liver toxicity is critical. In addition, the safe use of drugs in patients with underlying liver disease is an important issue. This session will discuss new thinking related to the hepatic safety of drugs.

Learning Objective :
  • Describe the FDA’s Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program and the exploration of predictive organ-chip technology to screen for drug induced liver toxicity (DILI) potential
  • Appraise different approaches to the assessment of hepatic safety data
  • List regulatory challenges in DILI risk assessment

Speaker(s)

Arie  Regev, MD

Screening, Monitoring, and Managing of Hepatitis B Virus (HBV) Reactivation in Clinical Trials with Immunosuppressing or Immunomodulating Drugs

Arie Regev, MD

Eli Lilly and Company , United States

Vice President, Medical Global Patient Safety

Representative Invited

Speaker

Representative Invited

FDA, United States

Vanitha  Sekar

Speaker

Vanitha Sekar

FDA, United States

Division Director Supervisor

Representative Invited

Speaker

Representative Invited

Abbvie, United States

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