ICH Project The 28th ICH Informal Debriefing Session
August 05, 2013 The
28th ICH
Informal Debriefing Sessionwas held on
July 26,2013
to report and discuss the outcomes of the ICH Brussels Meeting (June 1-6, 2013, Brussels, Belgium) and to share information on ICH activities and progress with the general public, including companies in charge of drug development and safety assurance. The 28th ICH Brussels Meeting was held on July 26, 2013, at Tsuda Hall in Tokyo, Japan.
The session began with a general report on the latest developments in ICH, followed by reports and Q&A sessions on trends in the topics of electronic standards for the communication of regulatory information, safety, and quality from various topic experts.
The program, timetable, and presentation materials for this symposium are attached below for your direct viewing. Unauthorized copying or reproduction of the attached materials is strictly prohibited.
Date, Time and Location
| Date and Time | Location |
|---|---|
| July 26, 2013 (Friday) 10:00-16:00 | Tsuda Hall
1-18-24 Sendagaya, Shibuya-ku, Tokyo |
Information, Program
Presentation Materials
| Presentations | Speakers | |
|---|---|---|
|
| Hironobu Saito (Daiichi Sankyo) | |
|
| KURAJIRO KISHI (JPMA) | |
| Trends in the topic of electronic standards for the communication of drug regulatory information | 03_E2B (R3) Data items for transmitting individual case safety report (567KB) | Ayumi ENDO (Japan Pharmaceutical Manufacturers Association) |
| Akiyo Fujikawa (Daiichi Sankyo) | ||
| Trends in Safety Topics | Shigeru Hisada (Asuka Pharmaceutical) | |
| Dai Nakae (Tokyo Metropolitan Institute of Public Health) | ||
| Trends in Quality Topics | Masayuki MISHIMA (Chugai Pharmaceutical) | |
| Tetsuhito Baoda (Mochida Pharmaceutical Co., Ltd.) |