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 February 17, 2010.

This workshop aimed to provide the explanation of the background and the revised guideline of E2B (R3) before collecting public comments. With regards to this revision, 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 370 participants from both pharmaceutical industries and regulatory authorities attended this workshop and had vigorous Q&A discussion.

The workshop was organized by the Japan Pharmaceutical Manufacturers Association (JPMA). All the presentation used at this 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: February 17, 2010 1:00 p.m.-5:00 p.m.

Presentation materials Speakers
00_Welcoming Address(PDF 113 KB) Kohei Wada, JPMA
01_ICH E2B(R3): Contents(PDF 592 KB) Ayumi Endo, MHLW(PMDA)
02_Contents of Health Level 7 (HL7)(PDF 1,7MB) Daisuke Koide, MHLW(PMDA/Tokyo University)
03_ICH E2B(R3) Implementation Guide, Contents of ICSR(PDF 599KB) Manabu Inoue, JPMA

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