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Tokyo Big Sight

Nov 10, 2019 9:30 AM - Nov 12, 2019 5:40 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S24] Have You Already Had a Labeling with New Format? How to Read New Format of Labeling and Impact for Implementation on Medical Practice

Session Chair(s)

Hideo  Nakada, RPh

Hideo Nakada, RPh

Deputy Associate Manager, Department of Hospital Pharmacy

Keio University, Japan

In April 2019, the official guidelines for the new labeling format came into force, and certain specific products with labeling in line with these new guidelines have actually begun to reach the medical field. This session will present practical examples of actions taken by pharmaceutical companies in response to these guidelines, their impact on other materials (interview forms, etc.), the impact of delivering products with labeling in this new format, and points to consider when reading labeling in this new format. We will also discuss how information should be disseminated and how to provide information to advance use of the new labeling format in future medical practice.


Natsumi  Kinoshita

Points of New Format of Labeling and Impact on Other Materials

Natsumi Kinoshita

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Reviewer, Office of Conformity Audit

Naoto  Tone

Company Initiatives in Delivery of Labeling with New Format to Medical Practice

Naoto Tone

Eli Lilly Japan K.K., Japan

Regulatory Scientist, Regulatory

Yuuki  Sasaki

Impact for Delivery of Labeling with New Format on Medical Practice from Pharmacists of Medical Institute Perspective

Yuuki Sasaki

Nihon University Hospital, Japan

Chief, Pharmaceutical Department

Yukio  Ikejima

Impact of New Format PI for Other Materials

Yukio Ikejima

Eisai Co., Ltd., Japan

Japan and Asia Pharmacovigilance Department, CMA HQ

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