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Session 4: Updates on Policies, Guidances, and Regulations – Asia
Session Chair(s)
Mamiko Kasho
Executive Director, Global PV Management Dept., Global Safety HQs
Eisai Co., Ltd., Japan
Yijing (Hellen) Zhang, MPharm
Executive Director, Global Patient Safety
Beigene, China
The session will provide updates on pharmacovigilance and risk management in countries of Asia region and how we comply with local specific requirements in those rapidly evolving environments. The focus this year will be describing pharmacovigilance requirements in India, some updates in China and Japan , and comparison of Pharmacovigilance System Master File requirements in Asia.
Learning Objective : - Describe the pharmacovigilance regulations in India through development to post-approval and the recent GVP inspection trend
- Explain what is required to do to comply with the pharmacovigilance requirements in China/Japan and key challenges
- Explain the increasing requirement for pharmacovigilance system master files or similar documents in Asian countries and compare the contents with the EU PV system master file
Speaker(s)
Comparison of PV System Master File requirements in Asia
Mamiko Kasho
Eisai Co., Ltd., Japan
Executive Director, Global PV Management Dept., Global Safety HQs
PV & Risk Management in India
Raza Mohammed, MD
OrciMed Life Science Private Limited, India
Chief Scientific Officer
Speaker
Yijing (Hellen) Zhang, MPharm
Beigene, China
Executive Director, Global Patient Safety