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Baltimore Marriott Waterfront

05 feb 2024 7:00 a.m. - 07 feb 2024 1:00 p.m.

700 Aliceanna Street , Baltimore, MD 21202

Global Pharmacovigilance and Risk Management Strategies Conference

Register for 2 or more short courses and save $150 off your registration fee!

Session 4: Updates on Policies, Guidances, and Regulations – Asia

Session Chair(s)

Mamiko  Kasho

Mamiko Kasho

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

Eisai Co., Ltd., Japan

Yijing (Hellen)  Zhang, MPharm

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)

Mamiko  Kasho

Comparison of PV System Master File requirements in Asia

Mamiko Kasho

Eisai Co., Ltd., Japan

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

Raza  Mohammed, MD

PV & Risk Management in India

Raza Mohammed, MD

OrciMed Life Science Private Limited, India

Chief Scientific Officer

Yijing (Hellen)  Zhang, MPharm

Speaker

Yijing (Hellen) Zhang, MPharm

Beigene, China

Executive Director, Global Patient Safety

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