ICH Project 27th ICH Public Meeting
November 02, 2012
The 27th ICH Public Meeting was held on December 14, 2012, at Yakult Hall in Tokyo, Japan, to share information on the progress of ICH with companies in charge of drug development and safety assurance. The meeting was held on December 14, 2012 at Yakult Hall in Tokyo, Japan.
In addition to a general report on the latest developments in ICH, this debriefing session included 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 of drugs. 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 (NIH) |
| 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 SHODA (Mochida Pharmaceutical Co., Ltd.) |