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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V7-S4] Future of e-Labeling in Japan

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

Lately, the idea of using technology for labeling has been in the spotlight. The initiative to provide digitalized product labeling to the healthcare professionals and patients is rapidly expanding worldwide. In EU, e-labeling has already been under discussion as EU Action Plan and a discussion on e-labeling has recently resumed in the U.S. Although the PMDA has already been providing the product labeling information on their web site, establishing digitalized labeling information, which is easier to understand, user friendly, and linked to the medical data such as electric medical record or health literacy, can further enhance patients’ safe drug administration. Conversely, concerns have arisen over abolition of paper product labeling enclosed in the commercial packs. Taking into account of US and EU situations, the future of e-labeling in Japan will be discussed including the possibility of personalized labeling as one of the future labeling providing methods.


Hidehito  Sekino

Current Status of Discussion on Introducing Electric Package Inserts - Regulator’s Viewpoint -

Hidehito Sekino

Ministry of Health, Labour and Welfare (MHLW), Japan

Director, Safety Division, Pharmaceutical Safety and Environmental Health Bureau

Shimon  Yoshida, PhD

Opportunities and Challenges with e-labeling from the Global Perspective

Shimon Yoshida, PhD

Pfizer Inc, United Kingdom

Executive Director, International Labeling Group, Global Regulatory Affairs

Haruko  Yamamoto, MD, PhD

Haruko Yamamoto, MD, PhD

National Cerebral and Cardiovascular Center, Japan

Executive Director