ICH Project The 33rd ICH Imminent Report Meeting
January 20, 2016
In order to share information on the progress of ICH with the public and companies responsible for drug development and safety assurance, the 33rd ICH Immediate Debriefing Session was held in Jacksonville, Florida, USA (December 5-10, 2015) to present and discuss the outcomes of the ICH Jacksonville Conference. The 33rd ICH Immediate Debriefing Session was held on January 15, 2016, at the All Dentsu Hall in Tokyo, Japan.
In this session, the latest developments in ICH, including a report on the establishment of the ICH Association, were presented, followed by reports and Q&A sessions with topical experts on trends in 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 strictly prohibited.
Date, Time, and Location
| Date and time | Location |
|---|---|
| January 15, 2016 (Friday) 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 | Presentations | Speakers |
|---|---|---|
| ICH Trends: Establishment of the ICH Association | Fumihito Takanashi (Ministry of Health, Labour and Welfare) | |
| Hironobu Saito (Daiichi Sankyo) | ||
| Trends in the topic of electronic standards for the communication of regulatory information on medicinal products | 03_M2 Electronic Standards for Communication of Drug Regulatory Information (548KB) | Katsuhiro Hashimoto (Dainippon Sumitomo Pharma) |
| Taku WATANABE (Japan Science and Technology Agency) | ||
| Trends in Quality Topics | 05_Q11 IWG Development and Manufacturing of Active Pharmaceutical Ingredients Q&A (641KB) | Kenji Ozaki (Shionogi) |
| Yasuhiro Kishioka (Japan Pharmaceutical Manufacturers Association) | ||
| Trends in Efficacy Topics | 07_E9(R1) Statistical principles for clinical trials (revised) (579KB) | Satoru Tsuchiya (Dainippon Sumitomo Pharma) |
| Kaoru Shinagawa (NIH) | ||
| 09_E17 Multinational collaborative clinical trial (MRCT) (265KB) | Shuji Kamada (JAEA) | |
| 10_E18 Collection of genomic samples and handling of genomic data (345KB) | Akihiro Ishiguro (NIH) | |
| Trends in Safety Topics | Akiyoshi NISHIKAWA (NIH) | |
| 12_S5(R3) Reproductive and Developmental Toxicity Test Methods for Drugs (Revised) (229KB) | Michio Fujiwara (Astellas) | |
| 13_S9 IWG Guideline Q&A for non-clinical evaluation of anti-cancer drugs (296KB) | Dai Nakae (Tokyo University of Agriculture) | |
| 14_S11 Non-clinical safety study using juvenile animals (253KB) | Kiyoshi Matsumoto (Takeda Pharmaceutical Company Limited) |