ICH Project 27th ICH Immediate Report
Nov 02, 2012
The 27th ICH Informal Meeting was held on December 14, 2012 at Yakult Hall in Tokyo to share the outcome of the ICH Regular Meeting held in San Diego, USA, from November 10 to 15, 2012, 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 place
| 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
Meeting Information/Program (298KB)
Presentation materials
| Presentation | Speaker | |
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Hironobu Saito (Daiichi Sankyo) |
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Yasuko Inokuma (Ministry of Health, Labour and Welfare) |
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Trends in Topics on Electronic Standards for Communication of Drug Regulatory Information |
02_E2B (R3) Data Items for Transmitting Individual Case Safety Report (549KB) |
Ayumi Endo (NIH) |
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Toru KIMURA (GlaxoSmithKline) |
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Trends in Efficacy Topics |
Yoko Hattori (Daiichi Sankyo) |
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Trends in Safety Topics |
Akiyoshi Nishikawa (National Institute of Health Sciences) |
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Kazuhiro HOSOI (Santen Pharmaceutical) |
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Masamitsu HONMA (National Institute of Public Health) |
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Trends in Quality Topics |
08_Q3D: Metal Impurities After the San Diego Meeting (397KB) |
Chikako SHIKATA (NIHS) |
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Tetsuhito Takarada（Mochida Pharmaceutical Co.) |
The End