ICH Project ICH E2B (R3) Implementation Guide Briefing Session

February 19, 2010 The

ICH E2B (R3) Implementation Guide Briefing Session was held on February 17, 2010 at Tower Hall Funabori, Edogawa-ku, Tokyo. More than 370 participants from regulatory authorities and the pharmaceutical industry attended the meeting, where a lively Q&A session was held.

ICH Guideline E2B (R3) "Data Items for Transmission of Individual Case Safety Report" will be revised, and a new message specification for exchanging such data items has been developed accordingly. As an electronic standard, the specification ISO standard, which was jointly standardized by HL7 and ISO (International Organization for Standardization), an organization outside ICH, will be used. For this reason, ICH has prepared the "ICH E2B (R3) Implementation Guide" (ICH E2B (R3) Implementation Guide), which defines how the ISO standard is to be used and will be implemented based on this guide. This time, a briefing session was held on the newly prepared "ICH E2B (R3) Implementation Guide," including its background.

The purpose of the meeting was to ensure that the contents of the ICH Implementation Guide are fully understood, considering that this is a new electronic standard to be introduced in Japan, and to solicit comments from a wide range of people based on the intent of this Implementation Guide in the public comment period scheduled after the meeting. It is expected that comments based on the intent of this Implementation Guide will be solicited widely from everyone at the public comment period scheduled after this briefing.

The ICH E2B (R3) Implementation Guide Briefing Session was held with the following program.
Opening Remarks, Presentation 1: "Overview of ICH E2B (R3)," Presentation 2: "Overview of Health Level 7 (HL7)," Presentation 3: "Overview of ICH E2B (R3) Implementation Guide and ICSR," General Q&A Session, Closing Remarks.

In his opening remarks, Mr. Kohei Wada, Chairperson of the ICH Project, on behalf of the organizers, made welcoming remarks, expressed his respect for the great efforts of the E2B (R3) Topic Members, and stated the purpose of holding this briefing session.

Under the moderator, Mr. Juichi Yoshinaga, the following presentations were made.
Ayumi Endo, Chief of Research and Analysis, Safety Department, Pharmaceuticals and Medical Devices Agency (PMDA), introduced the background of E2B(R3), changes, SDO process, and feasibility testing.
In Subject 2, "Overview of Health Level 7 (HL7)," Daisuke Koide, E2B (R3) Expert, Graduate School of Medicine, The University of Tokyo, explained what HL7 is, the purpose of HL7, reasons for using HL7, and the ICSR description item by item.
Under the title of "Overview of ICH E2B(R3) Implementation Guide and ICSR," ICH Project E2B(R3) Topic Leader Manabu Inoue explained the features of E2B in HL format, specific examples of E2B(R3) changes, and an overview of the Implementation Guide.
During the general discussion and Q&A session, speakers Ayumi Endo, Daisuke Koide, and Manabu Inoue answered questions from the audience and engaged in a lively discussion.
In his closing remarks, ICH coordinator Mr. Jiro Kishi summarized the session.

The presentation materials used in the ICH E2B(R3) Implementation Guide are attached below for your direct viewing.

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