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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



[V8-S6] Approaches to Implement Revision for New Format Labeling and Discussion How to Provide Information by Other Materials

Session Chair(s)

Takashi  Ohira

Takashi Ohira

Associate Director, Safety Management, Pharmacovigilance Department

Takeda Pharmaceutical Company Limited, Japan

In April 2019 official guidelines for new format of labeling will be enforced. Prior to that, PMDA consultation with some drugs to align with the new guidelines was started from July this year (first wave), and feedback from PMDA has been notified each company. Based on the disclosure of labeling of some model drugs, we introduce examples of them and discuss case studies and initiatives concerning tasks until actual implementation of revision of the labeling of the new guideline. Also, we would like to discuss contrivances in thinking about effective information provision with other materials such as interview form based on new format of labeling, and viewpoints from healthcare providers as readers of new format of labeling and points to note when providing information.


Akifumi  Kamata, PhD

Official Guidelines for New Format of Labeling and Findings of First Wave of Consultation for Labelling Revision

Akifumi Kamata, PhD

Pharmaceuticals and Medical Devices Agency, Japan

Office of New Drug I

Tatsumi  Inamura

Provision of Approaches to Implement Revision for New Format of Labeling from the Pharmaceutical Industry Perspective

Tatsumi Inamura

Novartis Pharma K.K., Japan

Group Manager, Prescribing Information Group, RA Functions Department

Hideo  Nakada, RPh

Provision of Approaches to Implement Revision for New Format of Labeling from Pharmacist of Medical Institute Perspective

Hideo Nakada, RPh

Keio University, Japan

Deputy Associate Manager, Department of Hospital Pharmacy

Shinya  Takemoto, MSc

Provision with Other Materials such as Interview Form based on New Format of Labeling and Providing Information

Shinya Takemoto, MSc

Chugai Pharmaceutical Co., Ltd., Japan

Group Manager, Safety Information Strategy Group, Risk Communication Department