ICH Project ICH Japan Symposium 2016

December 21, 2016

(The 35th ICH Immediate Report Meeting)

In order to share information on the progress of ICH with the general public as well as with companies responsible for drug development and safety assurance, the ICH Japan Symposium 2016 (35th ICH Immediate Report Meeting) was held on December 14, 2016 at All Dentsu Hall in Tokyo, Japan, to present and discuss the outcomes of the ICH Osaka Meeting (November 5 - 10, 2016, Osaka, Japan). was held on December 14, 2016 at All Dentsu Hall, Tokyo, Japan.

In this session, the experts from the Safety, Efficacy, and Quality Working Groups reported on the latest developments in ICH, including the results of the Osaka meeting and new topics, as well as on trends in the topic of electronic standards for the communication of regulatory information on medicinal products, followed by a Q&A session.

Approximately 170 people attended the meeting, and many questions were asked, indicating the high level of interest among the participants. The program, lecture timetable, and lecture materials for this debriefing session are attached below as files for direct viewing.
Unauthorized copying or reproduction of the contents of the attached materials is prohibited.

Date, time, and place of the meeting

Date and time Location
Wednesday, December 14, 2016, 10:00-15:45 All Dentsu Labor Hall (All Dentsu Hall)
3-6 Kanda Surugadai, Chiyoda-ku, Tokyo

Information and Program

Information / Program (309KB)

Presentation Materials

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Presentation Speakers
The Future of ICH: Trends in ICH 01_ICH Reform: Progress in the first year and future challenges (731KB) Nobumasa Nakajima (Ministry of Health, Labour and Welfare)
02_ICH Trends from JPMA's point of view
Focusing on strategic discussion/new topics (984KB)
Masashi Yokota (Daiichi Sankyo)
Trends in topics related to electronic standards for the communication of pharmaceutical regulatory information 03_E2B(R3)IWG "Data Items for Transmitting Individual Case Safety Report (ICSR) (837KB) Ayumi ENDO (Japan Synchrotron Radiological Research Institute)
04_M8 eCTD IWG/EWG (552KB) Taku Watanabe (JAEA)
Trends in Safety Topics 05_S5(R3) Reproductive Toxicity Test Methods for Drugs (Revised) (244KB) Michio Fujiwara (Astellas)
06_S11 Non-clinical studies for pediatric drug development (321KB) Yuji Takahashi (NIHS)
07_M10 Bioanalytical Method Validation of Drug Concentration in Biological Samples Bioanalytical Method Validation (952KB) ISHII, Akiko (NIHS) Akiko ISHII (NIHS)
Trends in Efficacy Topics 08_E9(R1) (204KB) Tomonori Ando (NIH)
09_E17 General principles for planning and design of global clinical trials (423KB) Shuji Kamada (NIMS)
10_E18 Collection of genomic samples and handling of genomic data (304KB) (in Japanese) Yu SAKAMOTO (NIMS)
Trends in Quality Topics 11_Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (516KB) Yasuhiro Kishioka (JAEA)
12_M9 Biopharmaceutics Classification System-based Biowaivers (265KB) Naomi Nagai (JAEA)
 

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