ICH Project The 27th ICH Informal Debriefing Session
November 02, 2012
The 27th ICH Readiness Briefing Session was held on December 14, 2012 at Yakult Hall in Tokyo to share the outcome of the ICH Regular Meeting held on November 10-15, 2012 in San Diego, U.S.A. with companies in charge of drug development and safety assurance. The meeting was held at Yakult Hall in Tokyo, Japan, on December 14, 2012.
In addition to a general report on the latest developments of the ICH, the symposium featured reports and Q&A sessions by subject matter experts on trends in topics related to electronic standards for the communication of regulatory information, efficacy, safety, and quality. The program, timetable, and presentation materials for this symposium are attached below as files for direct viewing.
Unauthorized copying or reproduction of the attached materials is strictly prohibited.
Date, Time and Location
| Date and Time | Location |
|---|---|
| Friday, December 14, 2012, 10:00-16:00 | Yakult Honsha Building, 1-1-19 Higashi-Shinbashi, Minato-ku, Tokyo |
Information and Program
Presentation Materials
| Presentations | Speakers | |
|---|---|---|
|
| Hironobu Saito (Daiichi Sankyo) | |
|
| Yasuko Inokuma (Ministry of Health, Labour and Welfare) | |
| Topic Trends in Electronic Standards for the Communication of Drug Regulatory Information | 02_Data items for transmitting E2B (R3) individual case safety report (549KB) | Ayumi ENDO (Japan Health Sciences Agency) |
| Toru Kimura (GlaxoSmithKline) | ||
| Trends in Efficacy Topics | Yoko Hattori (Daiichi Sankyo) | |
| Trends in Safety Topics | Akiyoshi NISHIKAWA (National Institute of Public Health) | |
| Kazuhiro Hosoi (Santen Pharmaceutical) | ||
| Masamitsu HONMA (National Institute of Public Health) | ||
| Trends in Quality Topics | Chikako SHIKATA (National Institute of Public Health) | |
| Tetsuhito Baoda (Mochida Pharmaceutical Co., Ltd.) |