ICH Project 31st ICH Immediate Report
Jan 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 Session) on the outcomes of the ICH Lisbon Conference (November 8-13, 2014, Lisbon, Portugal) was held on December 11, 2014, at Nagai Memorial Hall in Tokyo. 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. Please note that the contents of the attached materials may not be copied or reproduced without prior permission.
Date, time and place
| 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, Japan |
Information and Program
Presentation materials
| Presentations Presentation materials |
Speakers Speakers |
|
|---|---|---|
|
|
Kurajiro Kishi (Pharmaceutical Manufacturers Association of Japan) |
|
|
Trends in Topics on Electronic Standards for 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 Non-clinical evaluation Q&A of antineoplastic agents (299KB) |
Chihiro Nishimura (Nippon Kayaku) |
|
|
Trends in Efficacy Topics |
Seiki Kanazawa (Astellas Pharma Inc.) |
|
|
07_E9(R1) Statistical Principles for Clinical Trials Addendum (507KB) |
Satoru Tsuchiya（Dainippon Sumitomo Pharma Co.) |
|
|
Masahiro Ozaki (UCB Japan) |
||
|
Yoshiaki Uyama (Japan Science and Technology Agency) |
||
|
Akihiro Ishiguro（National Institute for Health Sciences) |
||
|
Yukiko Komori (NIMS) |
||
|
Trends in Quality Topics |
Toshinori Azuma（General Organization of Japan) |
|
|
Tetsuhito Takarada（Mochida Pharmaceutical Co.) |
||
|
14_Q12 Management of pharmaceutical product life cycle (182KB) |
Yasuhiro Kishioka (Natl.) |
The End