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[Session 5] What’s New for Labeling and Risk Management in East Asia?
Session Chair(s)
Rie Matsui, RPh
Senior Director, Regional Labeling Head for APAC, International Labeling
Pfizer R&D Japan G.K., Japan
Labeling is the major “routine” risk minimization element in the risk management plan (RMP). This session provides updates on labeling and risk management in East Asia, in response to regulations that have been revised and/or newly issued in this region. The status of implementing RMPs, including patient information, in Korea, as well as labeling and labeling updates in China will be discussed. This session will also address one of the hottest topics across all regions, the status of electronic labeling. Panel discussion will address how ICH E17 will impact RMPs and labeling in this region.
Speaker(s)
Regulation for RMP under MFDS and Recent Experiences
Bee Kim
Novartis Korea Ltd., Korea, Republic of
Country Patient Safety Head, Korea, Novartis Patient Safety, GDD
Labeling Regulation in China
Jason (Jing) Chen, MPharm
Pfizer (China) R&D Co., Ltd., China
International Labeling Asia Team Lead
Emerging Trends of Electronic Labelling in Asia Pacific
Fengyun(Vicky) Han
Johnson & Johnson Pte. Ltd., Singapore
Senior Director, Head of Regulatory Policy for Asia Pacific