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Bethesda North Marriott Hotel and Conference Center

Feb 06, 2023 1:00 PM - Feb 09, 2023 12:35 AM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Pharmacovigilance and Risk Management Strategies Conference

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

Session 1: Global Safety Regulatory Updates: Japan and China Regions

Session Chair(s)

Mamiko  Kasho

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


Mary  Thanh Hai, MD


Mary Thanh Hai, MD

FDA, United States

Deputy Director for Clinical, OND, CDER

Yijing (Hellen)  Zhang, MPharm


Yijing (Hellen) Zhang, MPharm

Beigene, China

Executive Director, Global Patient Safety

Mamiko  Kasho


Mamiko Kasho

Eisai Co., Ltd., Japan

Executive Director, Global PV Management Dept., Global Safety HQs

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