ICH Project ICH E2B (R3) Implementation Guide Briefing
July 13, 2011
ICH E2B (R2) “Data Elements for the Transmission of Individual Case Safety Reports” has been revised and is now ICH E2B (R3) “Data Elements and Message Specifications for the Transmission of Individual Case Safety Reports.” In conjunction with this revision, new message specifications for transmitting these data elements have been developed.For this electronic standard, we will utilize the ISO standard, which was jointly developed by HL7 and ISO (International Organization for Standardization), both of which are organizations outside the ICH. Therefore, the ICH has created an “ICH Implementation Guide” that defines how to use the ISO standard, and implementation will proceed based on this guide.At the ICH regular meeting held in Cincinnati, USA, starting on June 11, this topic reached Step 2. We held an informational session regarding the newly created “ICH E2B (R3) Implementation Guide,” including an overview of the background leading up to this development.
This briefing was organized with the aim of ensuring a thorough understanding of the ICH Implementation Guide, given that this is a new electronic standard being introduced in Japan. We also ask that, during the public comment period scheduled to begin in August following this briefing, you submit comments that take into account the intent of the Implementation Guide.
More than 300 stakeholders from the pharmaceutical industry and other related fields attended this briefing, and a lively question-and-answer session took place.
Please note that unauthorized copying or reproduction of the attached materials listed below is prohibited.
Date, Time, and Venue
| Date and Time | Location |
|---|---|
| Monday, July 11, 2011, 10:00 a.m. – 4:50 p.m. | Tower Hall Funabori Main Hall , 4-1-1 Funabori, Edogawa-ku, Tokyo |
Information and Program
Workshop Materials
| Presentations | Speakers |
|---|---|
| 1 Opening Remarks (188KB) | Kohei Wada
Chairperson, ICH Project |
| 2 Overview of ICH E2B (R3): Focusing on the Overview of ICSRs and a Comparison with the 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 for ICH Project E2B (R3), Japan Pharmaceutical Manufacturers Association |
| 4 Overview of Health Level 7 (HL7) (1,191 KB) | Daisuke Koide
Graduate School of Medicine, The University of Tokyo E2B (R3) Expert |
| 5 Points to Consider When Developing Tools for ICH E2B (R3) (2,733 KB) | Tsuyoshi Masuda
Research Collaborator, Ministry of Health, Labor and Welfare Scientific Research Project “Study on the Transmission of Safety Information for Pharmaceuticals and Medical Devices in the Context of Internationalization” (Okada Group) |