ICH Project 28th ICH Immediate Report
Aug 05, 2013
In order 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 Informal Debriefing Session was held on July 26, 2013 at Tsuda Hall in Tokyo to report and discuss the outcomes of the ICH Brussels Meeting (Brussels, Belgium, June 1-6, 2013). 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 place
| Date and Time | Location |
|---|---|
| Friday, July 26, 2013, 10:00-16:00 | Tsuda Hall
1-18-24 Sendagaya, Shibuya-ku, Tokyo |
Information and Program
Presentation materials
| Presentation | Speaker | |
|---|---|---|
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Hironobu Saito (Daiichi Sankyo) |
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Kurajiro Kishi (Pharmaceutical Manufacturers Association of Japan) |
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Trends in Topics on Electronic Standards for Communication of Drug Regulatory Information |
03_E2B (R3) Data Items for Transmitting Individual Case Safety Report (567KB) |
Ayumi Endo (NIH) |
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Akiyo Fujikawa (Daiichi Sankyo) |
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Trends in Safety Topics |
Shigeru Hisada (Asuka Pharmaceuticals) |
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Dai Nakae（Tokyo Metropolitan Institute of Public Health) |
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Trends in Quality Topics |
Masayuki Mishima (Chugai Pharmaceutical) |
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Tetsuhito Takarada（Mochida Pharmaceutical Co.) |
The End