ICH Project 28th ICH Public Meeting
August 05, 2013
The 28th ICH Public Meeting was held on July 26, 2013 at Tsuda Hall in Tokyo, Japan, 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 Immediate Debriefing Session 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 with topical experts on trends in electronic standards for the communication of regulatory information, safety, and quality.
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 and 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 (NIH) |
| 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.) |