ICH Project The 31st ICH Immediate Debriefing Session
January 15, 2015
In order to share information on the progress of ICH with companies in charge of drug development and safety assurance as well as the general public, a debriefing session (the 31st ICH Immediate Briefing) on the outcomes of the ICH Lisbon Meeting (November 8 - 13, 2014, Lisbon, Portugal) was
heldon
December 11,2014. was held on December 11, 2014 at Nagai Memorial Hall in Tokyo, Japan.
In this session, we reported on the current status and the latest developments of ICH Reform in general, as well as on trends in the topics of electronic standards for the communication of regulatory information, efficacy, safety, and quality, with reports from experts on each topic, followed by a question-and-answer 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 place of the meeting
| 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 (NIHO) | ||
| Akihiro Ishiguro (JAEA) | ||
| Yukiko Komori (JAEA) | ||
| Trends in Quality Topics | Toshinori Azuma (JAEA) | |
| Tetsuhito Baoda (Mochida Pharmaceutical Co., Ltd.) | ||
| 14_Q12 Management of pharmaceutical product life cycle (182KB) | Yasuhiro Kishioka (NIHS) |