ICH Project ICH Japan Symposium 2010
December 22, 2010
ICH Japan Symposium 2010 (23rd ICH Imminent Report Meeting)
ICH Public Meeting: ICH Japan Symposium 2010
As a forum for presentation and discussion of the outcomes of the ICH Fukuoka Meeting (November 6-11, 2010, Fukuoka, Japan), the third ICH regional meeting in the Japan region was held on December 2, 2010, at Tsuda Hall, Tokyo, under the title "ICH Japan Symposium 2010".
The symposium was held with the following program. In Part I, presentations and discussions on the progress and achievements of the Expert Working Groups at the Fukuoka Conference were made as trends in each topic. In Part II, a special session, a general discussion on pharmacovigilance was held with the participation of experts from both the business and government sides. This session included a comprehensive discussion on E2-related guidelines (E2A, E2B, E2D, E2E, and E2F), including the Periodic Safety Update Report (PSUR) for E2C marketed drugs, and gaps among regions and guidelines.
The program, presentation timetable, and presentation materials of this symposium are attached below as files for direct viewing.
In addition, the workshop materials on "Trends in Quality Topics: Q-IWG Quality Implementation Working Group" in the collection of presentation materials can be viewed at the ICH Q8, Q9, and Q10 Guidelines Operational Practices Workshop.
Unauthorized copying or reproduction of the attached materials is prohibited.
Date, time and place
| Date and time | Location |
|---|---|
| Thursday, December 2, 2010 10:00-16:40 | Tsuda Hall
1-18-24 Sendagaya, Shibuya-ku, Tokyo |
Information, Program
Presentation Materials
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