ICH Project 31st ICH Public Meeting for Immediate Release
January 15, 2015
The 31st ICH Public Meeting was held on December 11, 2014 at the Nagai Memorial Hall in Tokyo, Japan, to share information on the progress of ICH with the general public and companies in charge of drug development and safety assurance. The meeting was held on December 11, 2014, at Nagai Memorial Hall in Tokyo, Japan.
In this session, the ICH experts reported on the current status of ICH Reform and the latest developments in electronic standards for the communication of regulatory information, efficacy, safety, and quality, followed by a Q&A session.
Approximately 300 participants attended the meeting, and many questions were asked, indicating the high level of interest among the participants. The program, timetable, and presentation materials are attached below for your direct viewing. Unauthorized copying or reproduction of the contents of the attached materials is prohibited.
Date, Time, and Location
| Date and time | Location |
|---|---|
| Thursday, December 11, 2014, 10:00-16:50 | The Pharmaceutical Society of Japan Nagai Memorial Hall
2-12-15 Shibuya, Shibuya-ku, Tokyo |
Information and Program
Presentation Materials
| Presentations Presentation materials | Speakers Speakers | |
|---|---|---|
|
| KURAJIRO KISHI (JPMA) | |
| Trends in the topic of electronic standards for the communication of drug regulatory information | Manabu Inoue (MSD) | |
| Taku Watanabe (NIH) | ||
| Trends in Safety Topics | 04_S5(R3) Reproductive and Developmental Toxicity Study (336KB) | Michio Fujiwara (Astellas) |
| 05_S9 Q&A on nonclinical evaluation of anti-cancer drugs (299KB) | Chihiro Nishimura (Nippon Kayaku) | |
| Trends in Efficacy Topics | Seiki Kanazawa (Astellas Pharma Inc.) | |
| 07_E9（R1）Statistical Principles of Clinical Trials Addendum (507KB) | Satoru Tsuchiya (Dainippon Sumitomo Pharma) | |
| Masahiro Ozaki (UCB Japan) | ||
| Yoshiaki Uyama (NIH) | ||
| Akihiro Ishiguro (NIH) | ||
| Yukiko Komori (NIH) | ||
| Trends in Quality Topics | Toshinori Azuma (NIH) | |
| Tetsuhito Baoda (Mochida Pharmaceutical Co., Ltd.) | ||
| 14_Q12 Management of pharmaceutical product life cycle (182KB) | Yasuhiro Kishioka (NIH) |