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東京ビッグサイト

2017年11月12日 (日) 午前 9:30 - 2017年11月14日 (火) 午後 5:30

〒135-0063, 東京都江東区有明3-11-1

第14回DIA日本年会

[V3-S3] What Needs to Be Done for Creating Labeling Based on the New Revision of Items to be Included?

Session Chair(s)

Ken  Nakajima, RPh

Ken Nakajima, RPh

Quality Assurance Division Safety Management Department

Otsuka Pharmaceutical Factory, Inc, Japan

The Japan labeling regulations has been amended for the first time in 20 years and will be implemented in 3 years, which means that each company needs to prepare labeling according to the new revision of the labeling regulations. In order to do so, various preparations including verification of rationale of the current items and review of the latest data may be needed. In this session, PMDA will provide details on not just the summary of the new revision of items to be included, but points to be practically considered from the standpoint of PMDA. Also, as we need to observe our reality, action items will be picked up from a corporate perspective and will be discussed. The best practices and challenges for revision of labeling should be shared and discussed. A speaker from multinational companies will describe points to be considered as foreign-based companies, especially how to proceed this project including the communication between HQ. In addition, a difference in approach between foreign-based companies and domestic HQ companies will be discussed.

Speaker(s)

Akifumi  Kamata, PhD

Points to Revision of Package Inserts Based on the New Revision of Guide to Drafting Package Inserts -from the Standpoint of PMDA-

Akifumi Kamata, PhD

Pharmaceuticals and Medical Devices Agency, Japan

Office of New Drug I

Hanako  Saito

Discussion of Best Practice and Challenges for Revision of Labeling

Hanako Saito

Daiichi Sankyo Co., Ltd., Japan

Senior Director, Safety and Risk Management Dept., Safety Information Mgmt Group

Jun  Ishikawa

Issues and Solutions for Addressing the New Revision of Guide to Drafting Package Inserts -from the Standpoint of Global Company-

Jun Ishikawa

Pfizer Japan Inc., Japan

Team Lead, International Labeling Group - Japan

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