ICH Project 34th ICH Immediate Report
Jul 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 the general public, the 34th ICH Immediate Debriefing Session was held on July 21, 2016 at All Dentsu Hall in Tokyo, as a forum for presentation and discussion of the outcomes of the ICH Lisbon Meeting (June 11 - 16, 2016, Lisbon, Portugal). The 34th ICH Immediate Debriefing Session was held on July 21, 2016, at the All Dentsu Hall in Tokyo, Japan.
In this briefing 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.
Please note that the attached materials may not be copied or reproduced without permission
Date, time and place
| Date and Time | Location |
|---|---|
| Thursday, July 21, 2016, 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 | Presentation | Speaker |
|---|---|---|
|
ICH Trends |
Fumihito TAKANASHI (Ministry of Health, Labour and Welfare) |
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Hironobu Saito (Daiichi Sankyo) |
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03_ICH developments on IEC (Industry Executive Council) (423KB) |
Masashi Yokota (Daiichi Sankyo) |
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Trends in Safety Topics |
04_S5(R3) Reproductive and Developmental Toxicity Test Methods for Drugs (Revised) (243KB) |
Michio Fujiwara (Astellas) |
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05_S11 Non-clinical safety studies using juvenile animals (417KB) |
Yuji TAKAHASHI (NIHS) |
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Trends in Quality Topics |
06_Q11 IWG Q&A on the Development and Manufacturing of Active Pharmaceutical Ingredients (810KB) |
Kazunori Takagi (General Pharmaceuticals Organization of Japan) |
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Masaaki Wada (Shionogi) |
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Trends in Efficacy Topics |
Hazuki Takaura (NIH) |
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09_E9(R1) Statistical Principles for Clinical Trials (Revised) (653KB) |
Satoru Tsuchiya（Dainippon Sumitomo Pharma Co.) |
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Michiyo Sakiyama (NIH) |
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Trends in Topics on Electronic Standards for Communication of Drug Regulatory Information |
Takashi Noren (NIMS) |
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Katsuhiko Ichimaru (NIH) |
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Trends of topics with new developments |
13_S9 IWG Guidelines for the Non-clinical Evaluation of Antineoplastic Drugs Q&A (300KB) |
Dai Nakae（Tokyo Univ. of Agr.) |
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14_E17 General principles for planning and design of global clinical trials (916KB) |
Yoshiaki Uyama (Japan Science and Technology Agency) |
The End