ICH Project ICH Japan Symposium 2010
December 22, 2010
ICH Japan Symposium 2010 (23rd ICH Public Meeting)
ICH Public Meeting: ICH Japan Symposium 2010
As a forum for presenting and discussing the outcomes of the ICH Fukuoka Meeting (November 6–11, 2010, Fukuoka City), the third ICH Regional Meeting in the Japan region, titled “ICH Japan Symposium 2010,” was held on December 2, 2010, at Tsuda Hall in Tokyo.
The symposium was held according to the following program. First, in Part I, presentations and discussions were held on the progress and outcomes of the expert working groups at the Fukuoka Conference, covering trends in various topics. In Part II, a special session was held as a comprehensive discussion on pharmacovigilance, with the participation of experts from both the industry and regulatory sectors.During this session, a comprehensive discussion was held regarding the E2-related guidelines (E2A, E2B, E2D, E2E, E2F), including the E2C Periodic Safety Update Report (PSUR) for over-the-counter drugs, covering gaps between regions and between guidelines.
The program, presentation schedule, and presentation materials for this symposium are attached below and can be viewed directly.
Please note that the presentation materials titled “Trends in Quality-Related Topics: Q-IWG Quality Implementation Working Group” are available for viewing at the ICH Q8, Q9, and Q10 Guidelines Practical Training Workshop.
Please note that unauthorized copying or reproduction of the attached materials is prohibited.
Date, Time, and Venue
| Date and Time | Location |
|---|---|
| Thursday, December 2, 2010, 10:00 a.m.–4:40 p.m. | Tsuda Hall , 1-18-24 Sendagaya, Shibuya-ku, Tokyo |
Information and Program
Presentation Materials
You can scroll horizontally