ICHPharmaceutical Regulations in Japan

Workshop on the ICH E2C (R2) Guideline

Workshop on the ICH E2C (R2) Guideline was held in Japan which took place at the Tower Hall Funabori, Edogawa-ku in Tokyo on January 18, 2012.

This workshop aimed to provide the explanation of the background and the revised guideline, Periodic Benefit-Risk Evaluation Report (PBRER) which was intended to be a common standard for periodic benefit-risk evaluation reporting on marketed products (including approved drugs that are under further study) among the ICH regions.

Approximately 200 participants from not only pharmaceutical industries but also relevant industries attended this workshop and had vigorous Q&A discussion.

The workshop was jointly organized by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ, non-profit organization) and supported by the Federation of Pharmaceutical Manufacturers' Associations of Japan, the Pharmaceutical Manufacturers' Association of Tokyo, the Osaka Pharmaceutical Manufacturers Association and the Japan Pharmaceutical Association. All the presentation used at the workshop is available in Japanese as below.

Working Language: Japanese
Simultaneous English-Japanese Translation: Not Available
None of this publication may be reproduced by any means without the prior permission of the copyright owner.

Location: Tower Hall Funabori, 4-1-1, Funabori, Edogawa-ku, Tokyo, Japan
Date: January 18, 2012 1:00 p.m.-4:45 p.m.

Presentation materials Speakers
01_Background and present status of Step 2 Guideline and new regulation on pharmacovigilance in EU(PDF 840KB) Yoko Hattori, JPMA
02_Introduction: Background, Objectives, Scope of the PBRER (Guideline 1.~1.3)(PDF 1,304KB) Kazuyo Maruchi, JPMA
03_ICH E2C(R2) Step2 Guideline General Principles(Guideline 2.1~2.8)(PDF 1,951KB) Yukiko Watabe, JPMA
04_ICH E2C(R2) Guidance on contents of the PBRER(Guideline 3.11~3.14)(PDF 1,815KB) Noriko Adachi, JPMA
05_ICH E2C(R2) Guidance on contents of the PBRER(Guideline 3.15~3.19)(PDF 2,660KB) Motonobu Sakaguchi, JPMA

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