ICH Project 33rd ICH Immediate Report
Jan 20, 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 Japan Pharmaceutical Manufacturers Association (JPMA) will hold the 33rd ICH Immediate Debriefing Session as a forum for presentation and discussion of the outcomes of the ICH Jacksonville Meeting (December 5 - 10, 2015, Jacksonville, Florida, USA) on January 15, 2016, at the All Dentsu Hall in Tokyo, Japan. The meeting was held on January 15, 2016, at All Dentsu Hall in Tokyo, Japan.
The session began with a report on the latest developments in ICH, including the establishment of the ICH Association, followed by reports from subject matter experts and a Q&A session on trends in the topics of electronic standards for the communication of regulatory information, quality, efficacy, and safety.
The program, timetable, and presentation materials for this debriefing session are attached below as files for your direct review.
Unauthorized copying or reproduction of the attached materials is prohibited.
Date, time and place
| Date and Time | Location |
|---|---|
| Friday, January 15, 2016, 10:00-16:25 | All Dentsu Labor Hall (All Dentsu Hall)
3-6 Kanda Surugadai, Chiyoda-ku, Tokyo |
Information and Program
Presentation materials
| Presentation materials | Presentation | Speaker |
|---|---|---|
|
Trends in ICH: Establishment of the ICH Association |
Fumihito TAKANASHI (Ministry of Health, Labour and Welfare) |
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Hironobu Saito (Daiichi Sankyo) |
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Trends in Topics on Electronic Standards for Communication of Drug Regulatory Information |
Katsuhiro Hashimoto (Dainippon Sumitomo Pharma Co., Ltd.) |
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Taku Watanabe (NIH) |
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Trends in Quality Topics |
05_Q11 IWG Development and Manufacturing of Active Pharmaceutical Ingredients Q&A (641KB) |
Kenji Ozaki (Shionogi) |
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Yasuhiro Kishioka (Natl.) |
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Trends in Efficacy Topics |
07_E9(R1) Statistical Principles for Clinical Trials (Revised) (579KB) |
Satoru Tsuchiya（Dainippon Sumitomo Pharma Co.) |
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Kaoru Shinagawa (Natl.) |
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Shuji KAMATA (Natl. Inst. of Health Sci.) |
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10_E18 Collection of genomic samples and handling of genomic data (345KB) |
Akihiro Ishiguro（National Institute for Health Sciences) |
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Trends in Safety Topics |
Akiyoshi NISHIKAWA (NIH) |
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12_S5(R3) Reproductive and Developmental Toxicity Test Methods for Drugs (Revised) (229KB) |
Michio Fujiwara (Astellas) |
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13_S9 IWG Guideline Q&A on Non-clinical Evaluation of Antineoplastic Agents (296KB) |
Dai Nakae（Tokyo Univ. of Agr.) |
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14_S11 Non-clinical safety studies using juvenile animals (253KB) (in Japanese) |
Kiyoshi MATSUMOTO (Takeda Pharmaceutical Company Limited) |
The End