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[V7-S4] Future of e-Labeling in Japan
Session Chair(s)
Rie Matsui, RPH
Senior Director, Regional Labeling Head for APAC, 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.
Speaker(s)
Current Status of Discussion on Introducing Electric Package Inserts - Regulator’s Viewpoint -
Director, Safety Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare (MHLW), Japan
Opportunities and Challenges with e-labeling from the Global Perspective
Executive Director, International Labeling Group, Global Regulatory Affairs, Pfizer Inc, United Kingdom
Haruko Yamamoto, MD, PHD
Executive Director, National Cerebral and Cardiovascular Center, Japan
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