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TOC Ariake Convention Hall

Mar 26, 2018 9:00 AM - Mar 27, 2018 6:00 PM

3-5-7 Ariake, , Koto-ku, Tokyo, 135-0063 Japan

12th DIA Asia New Drug Conference in Japan

[Session 5] What’s New for Labeling and Risk Management in East Asia?

Session Chair(s)

Rie  Matsui, RPh

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)

Bee  Kim

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

Jason (Jing)  Chen, MPharm

Labeling Regulation in China

Jason (Jing) Chen, MPharm

Pfizer (China) R&D Co., Ltd., China

International Labeling Asia Team Lead

Fengyun (Vicky)  Han

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

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