ICH Project Workshop on the ICH E2B (R3) Implementation Guide
February 17, 2010
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(113 KB) | Kohei Wada, JPMA |
| 01_ICH E2B(R3): Contents(592 KB) | Ayumi Endo, MHLW(PMDA) |
| 02_Contents of Health Level 7 (HL7)(1,7MB) | Daisuke Koide, MHLW(PMDA/Tokyo University) |
| 03_ICH E2B(R3) Implementation Guide, Contents of ICSR(599KB) | Manabu Inoue, JPMA |