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Session 1: Global Safety Regulatory Updates: Japan and China Regions
Session Chair(s)
Mamiko Kasho
Executive Director, Global PV Management Dept., Global Safety HQs
Eisai Co., Ltd., Japan
The session will provide global regulatory updates on pharmacovigilance and risk management focusing on Asia. We will discuss challenges in complying with the new regulatory requirements for patient safety. This session will provide an overview of the ICH E19 guideline and discuss the new and unique requirement in clinical safety reporting in Japan. We will also discuss the rapidly evolving pharmacovigilance environment in China and their clinical and post-marketing regulations.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe the new internationally harmonized guidance on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials
- Discuss the requirements in the new clinical reporting rule in Japan and their challenges
- Explain the pharmacovigilance regulations in China from development to post-approval and discuss their challenges
Speaker(s)
Speaker
Mary Thanh Hai, MD
FDA, United States
Deputy Director for Clinical, OND, CDER
Speaker
Yijing (Hellen) Zhang, MPharm
Beigene, China
Executive Director, Global Patient Safety
Speaker
Mamiko Kasho
Eisai Co., Ltd., Japan
Executive Director, Global PV Management Dept., Global Safety HQs
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