ICH Project 37th ICH Instant Reporting Session
Dec 25, 2017
In order to share information on the progress of ICH with companies in charge of drug development and safety assurance as well as with the general public, the 37th ICH Immediate Debriefing Session was held on December 15, 2017, at All Dentsu Hall in Tokyo, as a forum for presentation and discussion of the outcomes of the ICH Geneva Meeting (November 11 - 16, 2017, Geneva, Switzerland). The 37th ICH Immediate Debriefing Session was held on December 15, 2017, at the All Dentsu Hall in Tokyo, Japan.
In this meeting, the experts from the working groups reported on the latest developments in ICH, including the results of the Geneva meeting and new topics, as well as on trends in the topics of efficacy, quality, safety, and electronic standards for the communication of regulatory information on medicines, and answered questions. The event was attended by approximately 240 participants.
Approximately 240 people attended the meeting, and many questions were asked, indicating the high level of interest among the participants. The program, timetable, and presentation materials for this debriefing session are attached below as files for your direct viewing.
Please note that the attached materials may not be copied or reproduced without prior permission.
Date, time and place
| Date and Time | Location |
|---|---|
| Friday, December 15, 2017, 9:30-15:45 | All Dentsu Labor Hall (All Dentsu Hall)
3-6 Kanda Surugadai, Chiyoda-ku, Tokyo |
Information and Program
Presentation materials
| Presentation | Speaker |
|---|---|
|
Fumihito TAKANASHI (Ministry of Health, Labour and Welfare) |
|
|
Hironobu Hiyoshi (Pharmaceutical Manufacturers Association of Japan) |
|
|
03_E17 General principles for the planning and design of global clinical trials (1137KB) |
Yoshiaki Uyama (Japan Science and Technology Agency) |
|
04_E9(R1) Statistical principles for clinical trials (addendum) (439KB) |
Yuki Watanabe（Chugai Pharmaceutical Co.) |
|
Kinue Nishioka (NIMS) |
|
|
06_E8(R1) General guidelines for clinical trials (revised) (1309KB) |
Mutsuhiro Ikuma (NIMS) |
|
Shinichi Kijima (NIMS) |
|
|
08_Q3D(R1) Elemental Impurities (Revised) - PDE for Dermal and Transdermal Administration - (528KB) |
Akihiko HIROSE (National Institute of Health Sciences) |
|
09_M9 BCS-based Biowaivers |
Yukiko Komori (NIMS) |
|
10_S11 Non-clinical safety studies for pediatric drug development（264KB) |
Kiyoshi MATSUMOTO (Japan Pharmaceutical Manufacturers Association) |
|
Akiko ISHII (National Institute of Public Health) |
|
|
Takashi Noren (NIMS) |
|
|
13_M2 Electronic Standards for the Transmission of Drug Regulatory Information (454KB) |
Kohji SHOMOTO (Japan Pharmaceutical Manufacturers Association) |
|
Kayoko ICHIKAWA (Japan Pharmaceutical Manufacturers Association) |
The End