ICH Project ICH E2B (R3) Implementation Guide information session
Jul 13, 2011
ICH E2B (R2) "Data Items for Transmission of Individual Case Safety Report" has been revised and is now ICH E2B (R3) "Data Items for Transmission of Individual Case Safety Report and Message Specifications for Transmission". In line with this revision, a new message specification for transmitting the relevant data items has been developed. As the electronic standard, the ISO standard, which is a specification jointly standardized by HL7 and ISO (International Organization for Standardization), an organization outside ICH, will be used. Therefore, ICH has prepared an "ICH Implementation Guide" that defines how the ISO standard will be used and will be implemented based on this guide. 2 has been reached. The newly developed "ICH E2B (R3) Implementation Guide" including its background was presented at a briefing session this time.
Considering that this is a newly introduced electronic standard in Japan, this briefing session was planned to ensure that the participants fully understand the contents of the ICH Implementation Guide. In addition, we would like to invite you to submit comments based on the intent of the Implementation Guide during the public comment period scheduled after this briefing session in August.
More than 300 people from the pharmaceutical industry and other related parties attended the briefing, which was followed by a lively question-and-answer session.
Please note that the contents of the attached materials listed below may not be copied or reproduced without prior permission.
Date, time and place
| Date and Time | Location |
|---|---|
| July 11, 2011 (Monday) 10:00-16:50 | Tower Hall Funabori Main Hall
4-1-1 Funabori, Edogawa-ku, Tokyo |
Information and Program
Workshop Materials
| Presentation | Speaker |
|---|---|
| 1 Introduction (188KB) | Kohei Wada
ICH Project Chair |
| 2 Overview of ICH E2B (R3): Focusing on ICSR and comparison with current E2B (2,819 KB) | Ayumi Endo
（Senior Specialist, Investigation and Analysis Division, Safety Department 1, Pharmaceuticals and Medical Devices Agency (PMDA) |
| 3 ICH E2B (R3) Implementation Guide, Overview of ICSR (634 KB) | Manabu Inoue
Topic Leader, ICH Project E2B(R3), Japan Pharmaceutical Manufacturers Association (JPMA) |
| 4 Overview of Health Level 7 (HL7) (1,191 KB) | Daisuke Koide
E2B(R3), Graduate School of Medicine, The University of Tokyo Expert |
| 5 Considerations when Developing Tools for ICH E2B (R3) (2,733 KB) | Tsuyoshi Masuda
Research Collaborator, Okada Group, MHLW Science Research on Communication of Safety Information on Drugs and Medical Devices in the Context of Internationalization |
For inquiries, please contact
ICH Secretariat of the Pharmaceutical Manufacturers' Association of Japan
- Phone
- 03-3241-0326
The End