ICH Project Workshop on the ICH E2B (R3) Implementation Guide

July 11, 2011

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.

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