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Session 1105: PRE-MARKETING RISK ASSESSMENT
Session Chair(s)
Yuhong WANG, MD
Drug Safety Lead
Shanghai Roche Pharmaceuticals Ltd, China
Risk assessment occurs throughout a product’s lifecycle, from the early identification of a potential product, through the premarketing development process, and after approval during marketing. Premarketing risk assessment is particularly important as the assessment of underlying risks and benefits during the premarketing period is critical to the regulatory authority’s decision on product approval. Moreover, safety is the predominant reason why products are withdrawn from the marketplace, and Drug-Induced Liver Injury (DILI) remains the most common single cause of safety-related drug marketing withdrawals, as it has been for the past 50 years. This session is intended to share views from the perspective of industry, academia and regulatory authority on premarketing assessment of liver toxicity, provide an overview on DILI risk assessment and management in clinical development program, and give an update on the advances in DILI research worldwide and nationwide.
Speaker(s)
DILI Risk Assessment and Management in Clinical Development Program – Industry Perspective
Sean Zhao, MD, PhD
PV Quest, Inc., USA, China
Senior Pharmaceutical Consultant
Strengthening the Translational and Clinical Research on Drug-Induced Liver Injury (DILI) – Academic Perspective
Yimin MAO
RenJi Hospital, China
Professor
Huaqiong SHEN, MD, PhD
Jiangsu Hengrui Medicine Co., Ltd., China
Chief Medical Officer
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