ICHPharmaceutical Regulations in Japan

Workshop on the ICH E2B (R3) Implementation Guide

Workshop on the ICH E2B (R3) Implementation Guide was held in Japan which took place at the Tower Hall Funabori, Edogawa-ku in Tokyo on July 11, 2011.

This workshop aimed to provide the explanation of the revised guideline of E2B (R3) which reached Step 2 at the ICH Cincinnati meetings in June 2011. With regards to the revised guideline of E2B (R3), technical specifications were created in collaboration with Standards Development Organisations (SDOs), which uses the ISO/HL7 27953-2 ICSR message exchange standard. In order to leverage ISO standards, an Implementation Guide for E2B (R3) was developed by E2B EWG.

Over 300 participants from pharmaceutical 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: July 11, 2011 11:00 a.m.-4:50 p.m.

Presentation materials Speakers
01_Welcoming Address(PDF 35KB) Kohei Wada, JPMA
02_ICH E2B(R3): Contents of ICSR, comparing with current E2B(PDF 2,819 KB) Ayumi Endo, MHLW(PMDA)
03_ICH E2B(R3): Implementation Guide, Contents of ICSR(PDF 634KB) Manabu Inoue, JPMA
04_Contents of Health Level 7 (HL7)(PDF 1,191KB) Daisuke Koide, MHLW(PMDA/Tokyo University)
05_ICH E2B(R3) Points to Consider in tool development(PDF 2,733KB) Gou Masuda, MHLW(PMDA/KIS)

Page Top

  • Office of Pharmaceutical Industry Research(OPIR)
  • Global Health
  • Stop AMR
  • APAC