ICH Project ICH E2F Step 2 Guideline Briefing Session
October 10, 2008
ICH Topic E2F "Periodic Safety Update Reporting (DSUR) During Development" Step 2 Guideline Information Session was held on October 2, 2008 at Tower Hall Funabori, Edogawa-ku, Tokyo. 350+ pharmaceutical industry representatives attended.
ICH Topic E2F reached Step 2 (the stage of decision on the draft guideline, approval and informal announcement of the draft guideline in each country, and hearing of opinions) at the ICH Portland Meeting held in the United States in June 2008. The draft guideline for periodic safety update reporting during the development phase has been developed with the intention of becoming the standard for annual safety reporting in clinical trials across the ICH region.
Currently, a public comment period is underway (September-November) to hear opinions from the regulatory authorities.
This briefing session focused on explaining the contents of the draft guidelines, as these guidelines will be a newly introduced system in Japan. It is hoped that this will lead to a broad solicitation of comments based on the intent of the guideline in the ongoing pub-commentary process.
The ICH Topic E2F Step 2 Guideline Explanatory Meeting was held with the following program. Opening Remarks, Presentation 1: "Significance of DSUR," Presentation 2: "Contents of DSUR Step 2 Guideline," General Q&A, and Closing Remarks.
In his opening remarks, ICH Project Chair Kohei Wada, on behalf of the organizers, welcomed the audience, expressed his respect for the great efforts of the E2F Topic Members in reaching Step 2, and explained the purpose of holding this briefing session.
In the first presentation entitled "Significance of DSUR," Dr. Noriko Akagi, E2F Topic Leader of the ICH Project, introduced the background of the guideline review.
In the second session, titled "Contents of DSUR Step 2 Guideline," Yukiko Watanabe, Deputy Topic Leader of ICH Project E2F, together with Noriko Akagi, explained the contents of the guideline item by item, and introduced key points in reading the guideline and the background of the guideline description.
In the general Q&A session, Noriko Akagi, Yukiko Watanabe, Tomohiro Tsuji, and Mayumi Hagiwara, members of the same topic, answered questions that had been received by the day of the meeting and answered them. Finally, a lively question-and-answer session was held in the audience to promote interpretation of the draft guideline.
In his closing remarks, ICH coordinator Jiro Kishikura summarized this briefing session.
The contents of this ICH Topic E2F Step 2 Guideline Briefing Session can be viewed directly by clicking on the file attached below.
Contents of the Presentation of ICH Topic E2F Step 2 Guideline Briefing Session (215KB)
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