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Session 5: Asia & LATAM Updates
Session Chair(s)
E. Stewart Geary, MD
MD, Global Safety Officer
Eisai Co., Ltd., Japan
The session will provide an update on new developments in pharmacovigilance and risk management in Latin America and Asia. The focus will be on providing a broad outline of PV regulations especially where they deviate from ICH standards and recent developments or changes in these countries. Topics of special interest this year include the implementation of GVP in China and rollout of electronic package inserts in Japan.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand in broad outline the PV regulations in Asia (including Japan) and Latin America
- Learn of the most recent changes in regulations which affect risk management or pharmacovigilance in these countries
- Gain awareness of potential issues for PV compliance in these regions and how to address them
Speaker(s)
Pharmacovigilance in China
Vera Liang, MD
Pfizer (China) R&D Co., Ltd., China
Sr. Director, Drug Safety Unit Regional Head - APAC
Current Status and Recent Developments in Pharmacovigilance in Japan
Makoto Miyazaki, MSc
Japan Pharmaceutical Manufacturers Association (JPMA) / MSD K.K. , Japan
LATAM Safety Landscape and Regulatory Updates
Julio Guy Ciolfi Pinto, MD, MBA
Brazil
Director, Regional Safety Excellence LATAM