ICH Project ICH E2F Step 2 Guideline Workshops
October 10, 2008
A Guideline Workshop on the ICH Topic E2F “Development Safety Update Report (DSUR)” Step 2 Guidelines was held on October 2, 2008, at Tower Hall Funabori in Edogawa Ward, Tokyo. More than 350 representatives from the pharmaceutical industry attended.
ICH Topic E2F reached Step 2 (the stage of finalizing and approving the draft guideline, notifying member countries of the draft, and soliciting comments) at the ICH Portland Meeting held in the United States in June 2008.The periodic safety update reports during the development phase proposed in this draft guideline were developed with the intention of becoming the standard for annual clinical trial safety reports across the ICH region.
A public comment period is currently underway (September–November).
Since these guidelines will constitute a new system to be introduced in Japan, Guideline Workshops focused primarily on explaining the content of the draft guidelines. It is hoped that this will encourage a wide range of comments, grounded in the intent of the guidelines, during the public comment period currently underway.
The ICH Topic E2F Step 2 Guideline Workshops were held according to the following program: opening remarks; Presentation 1, “The Significance of the DSUR”; Presentation 2, “Contents of the DSUR Step 2 Guidelines”; a general Q&A session; and closing remarks.
In his opening remarks, Mr. Kohei Wada, Chairperson of the ICH Project, spoke on behalf of the organizers to extend a welcome, express appreciation for the tremendous efforts of the E2F Topic members in reaching Step 2, and outline the purpose of the briefing session.
In Presentation 1, titled “The Significance of the DSUR,” Ms. Noriko Akagi, ICH Project E2F Topic Leader, introduced the background of the guideline development.
Presentation 2, titled “Contents of the DSUR Step 2 Guidelines,” featured Ms. Noriko Akagi and Ms. Yukiko Watanabe, Deputy Topic Leader of the ICH Project E2F Topic, who explained the contents of the guidelines item by item, highlighting key points for readers and providing context for the guidelines’ wording.
During the general Q&A session, Ms. Noriko Akagi, Ms. Yukiko Watanabe, and Topic Group members Mr. Tomohiro Tsuji and Ms. Mayumi Hagiwara addressed questions submitted prior to the event and provided answers. Additionally, a lively Q&A session took place at the end of the event, which helped facilitate a better understanding of the draft guidelines.
In his closing remarks, ICH Coordinator Jiro Kishikura summarized the session.
The presentation materials from this ICH Topic E2F Step 2 Guideline Workshop are attached below and can be viewed directly.
Presentation Materials for the ICH Topic E2F Step 2 Guideline Workshops (215KB)