ICH Project ICH E2B (R3) Implementation Guide Briefing Session

February 19, 2010

A briefing session on the ICH E2B (R3) Implementation Guide was held on February 17, 2010, at Tower Hall Funabori in Edogawa Ward, Tokyo. More than 370 participants from regulatory authorities and the pharmaceutical industry attended, and a lively question-and-answer session took place.

The ICH Guideline E2B (R3), “Data Elements for the Transmission of Individual Case Safety Reports,” is being revised; accordingly, new message specifications for exchanging these data elements have been developed. As the electronic standard, the ICH will utilize the ISO standard—a specification jointly standardized by HL7 and ISO (International Organization for Standardization), both of which are organizations outside the ICH.Consequently, ICH has developed the “ICH E2B (R3) Implementation Guide,” which defines how to use the ISO standard, and implementation will proceed based on this guide.We recently held a briefing session on the newly created “ICH E2B (R3) Implementation Guide,” including an explanation of the background leading to its development.

Given that this is a new electronic standard being introduced in Japan, the briefing was organized with the aim of ensuring a thorough understanding of the contents of the ICH Implementation Guide. It is also expected that, during the public comment period scheduled to follow this briefing, participants will widely submit comments that take into account the intent of this Implementation Guide.

The ICH E2B (R3) Implementation Guide briefing session was held according to the following program:
Opening Remarks; Presentation 1: “Overview of ICH E2B (R3)”; Presentation 2: “Overview of Health Level 7 (HL7)”; Presentation 3: “Overview of the ICH E2B (R3) Implementation Guide and ICSR”; General Q&A; Closing Remarks.

In his opening remarks, Mr. Kohei Wada, Chairperson of the ICH Project Committee, delivered a welcome address on behalf of the organizers, expressed his appreciation for the tremendous efforts of the E2B (R3) Topic Members, and outlined the purpose of the briefing session.

Under the moderation of Mr. Juichi Yoshinaga, presentations on the following topics were given:
Presentation 1, titled “Overview of ICH E2B (R3),” was delivered by Ms. Ayumi Endo, Senior Investigator in the Safety Department at the Pharmaceuticals and Medical Devices Agency (PMDA). She introduced the background of E2B (R3), the changes, the SDO process, and feasibility testing.
Presentation 2, titled “Overview of Health Level 7 (HL7),” was delivered by Daisuke Koide, an E2B (R3) expert at the Graduate School of Medicine, The University of Tokyo. He explained what HL7 is, its objectives, the reasons for using HL7, and the contents of ICSR reports item by item.
Presentation 3, titled “Overview of the ICH E2B (R3) Implementation Guide and ICSR,” featured Mr. Manabu Inoue, ICH Project E2B (R3) Topic Leader, who explained the characteristics of the HL format for E2B, specific examples of changes in E2B (R3), and an overview of the Implementation Guide.
During the general discussion and Q&A session, presenters Ayumi Endo, Daisuke Koide, and Manabu Inoue engaged in a lively discussion and answered questions raised by the audience at the venue.
In his closing remarks, ICH Coordinator Kurajiro Kishi summarized the briefing.

The presentation materials used during the ICH E2B (R3) Implementation Guide Briefing are attached below, so you can view them directly.

　

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