ICH Project 33rd ICH Public Meeting
January 20, 2016
To widely share information on ICH developments with representatives from companies involved in drug development and safety assurance, as well as the general public, the 33rd ICH Immediate Report Meeting(December 5–10, 2015, Jacksonville, Florida, U.S.) and to facilitate discussion, the 33rd ICH Public Meeting was held on January 15, 2016, at the Zendentsu Hall in Tokyo.
At this briefing, the session began with a report on the latest ICH developments, including the establishment of the ICH Association. This was followed by presentations and Q&A sessions led by experts on topics such as electronic standards for the transmission of pharmaceutical regulatory information, as well as trends in quality, efficacy, and safety.
The program, presentation schedule, and presentation materials for this meeting are attached below and can be viewed directly at the following link:
Please note that unauthorized copying or reproduction of the attached materials is prohibited.
Date, Time, and Venue
| Date and Time | Venue |
|---|---|
| Friday, January 15, 2016, 10:00 a.m. – 4:25 p.m. | Zendentsu Labor Hall (Zendentsu Hall)
3-6 Kanda Surugadai, Chiyoda-ku, Tokyo |
Information and Program
Event Notice / Program (308KB)
Presentation Materials
| Presentation Materials | Presentation | Speakers |
|---|---|---|
| ICH Trends: Establishment of the ICH Association | Fumito Takanashi (Ministry of Health, Labour and Welfare) | |
| Hironobu Saito (Daiichi Sankyo) | ||
| Trends in Topics Related to Electronic Standards for the Transmission of Pharmaceutical Regulatory Information | Katsuhiro Hashimoto (Dainippon Sumitomo Pharma) | |
| Taku Watanabe (NIH) | ||
| Trends in Quality-Related Topics | 05_Q11 IWG Q&A on the Development and Manufacturing of Active Pharmaceutical Ingredients (641KB) | Kenji Ozaki (Shionogi & Co., Ltd.) |
| Yasuhiro Kishioka (NIH) | ||
| Trends in Topics Related to Efficacy | 07_E9 (R1) Statistical Principles for Clinical Trials (Revised) (579KB) | Satoru Tsuchiya (Dainippon Sumitomo Pharma) |
| Kaori Shinagawa (NIH) | ||
| Shuji Kamata (NIH) | ||
| 10_E18 Collection of Genomic Samples and Handling of Genomic Data (345KB) | Akihiro Ishiguro (NIH) | |
| Trends in Safety-Related Topics | Akika Nishikawa (National Institute of Public Health) | |
| Michio Fujiwara (Astellas) | ||
| 13_S9 IWG Guidelines on Nonclinical Evaluation of Antineoplastic Drugs: Q&A (296KB) | Hiroshi Nakae (Tokyo University of Agriculture) | |
| 14_S11 Nonclinical Safety Studies Using Juvenile Animals (253KB) | Kiyoshi Matsumoto (Takeda Pharmaceutical Company) |