ICH Project The 34th ICH Imminent Briefing Session
July 28, 2016
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 34th ICH Immediate Debriefing Session was held on July 21, 2016, as a forum for presentation and discussion of the outcomes of the ICH Lisbon Meeting (June 11 - 16, 2016, Lisbon, Portugal). was held on July 21, 2016 at All Dentsu Hall, Tokyo, Japan.
In this session, the latest developments of ICH, including the results of the Lisbon meeting and new topics, were reported by experts on the topics of safety, quality, efficacy, and electronic standards for the communication of regulatory information on medicinal products, followed by a Q&A session.
Approximately 220 people attended the meeting and many questions were asked, indicating the high level of interest among the participants. The program, lecture timetable, and presentation materials for this debriefing session are attached below as files for direct viewing.
(Unauthorized copying or reproduction of the attached materials is strictly prohibited.
Date, Time, and Location
| Date and time | Location |
|---|---|
| July 21, 2016 (Thursday) 10:00-16:15 | All Dentsu Labor Hall (All Dentsu Hall)
3-6 Kanda Surugadai, Chiyoda-ku, Tokyo |
Information and Program
Presentation Materials
| Presentation Materials | Presentations | Speakers |
|---|---|---|
| ICH Trends | Fumihito Takanashi (Ministry of Health, Labour and Welfare) | |
| Hironobu Saito (Daiichi Sankyo) | ||
| Masashi Yokota (Daiichi Sankyo) | ||
| Trends in Safety Topics | 04_S5(R3) Reproductive and Developmental Toxicity Test Methods for Drugs (Revised) (243KB) | Michio Fujiwara (Astellas) |
| 05_S11 Non-clinical safety study using juvenile animals (417KB) | Yuji TAKAHASHI (NIH) | |
| Trends in Quality Topics | 06_Q11 IWG Development and Manufacturing of Active Pharmaceutical Ingredients Q&A (810KB) | Kazunori TAKAGI (NIH) |
| Masaaki Wada (Shionogi) | ||
| Trends in Efficacy Topics | Hazuki Takaura (NIHO) | |
| 09_E9(R1) Statistical Principles for Clinical Trials (Revised) (653KB) | Satoru Tsuchiya (Dainippon Sumitomo Pharma) | |
| Michiyo Sakiyama (National Institute of Health Sciences (NIHS)) | ||
| Topic Trends in Electronic Standards for the Communication of Drug Regulatory Information | Takashi Noren (NIH) | |
| Katsuhiko ICHIMARU (NIHON Corporation) | ||
| Trends of newly developed topics | 13_S9 IWG Guideline for non-clinical evaluation of anti-cancer drugs Q&A (300KB) | Dai Nakae (Tokyo University of Agriculture) |
| 14_E17 General principles for planning and design of global clinical trials (916KB) | Yoshiaki Uyama (National Institute of Advanced Industrial Science and Technology) |