ICH Project ICH Japan Symposium 2013

December 24, 2013

ICH Japan Symposium 2013
(29th ICH Public Meeting)

ICH Japan Symposium 2013 (the 29th ICH Public Meeting) was held on December 10, 2013 at Tsuda Hall in Tokyo, Japan, as the official ICH meeting in Japan to share information on the progress of ICH with the general public, including companies responsible for drug development and safety assurance. The ICH Japan Symposium 2013 (the 29th ICH Symposium) was held on December 10, 2013 at Tsuda Hall in Tokyo, Japan.

The symposium began with a general report on the latest developments in ICH, followed by reports and Q&A sessions by experts from the Topic Working Groups on trends in the topics of electronic standards for the communication of regulatory information, efficacy, safety, and quality.

The symposium was attended by approximately 200 participants, and the topic chairs moderated a lively discussion, particularly on developments in the topic of safety, demonstrating the high level of interest among the participants.
The program, timetable, and presentation materials of the symposium are attached below for your direct viewing.
Unauthorized copying or reproduction of the attached materials is strictly prohibited.

Date, Time, and Location

Date and Time Location
Tuesday, December 10, 2013 10:00-16:40 Tsuda Hall
1-18-24 Sendagaya, Shibuya-ku, Tokyo

Information and Program

Information / Program (425KB)

Presentation Materials

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Presentations Speakers
01_Opening Remarks Hironobu Saito (Daiichi Sankyo)
02. History of ICH (316KB) Naoyuki Yasuda (Ministry of Health, Labour and Welfare)
03. The latest trend of ICH (265KB) KURAJIRO KISHI (JPMA)
Trends in the topic of electronic standards for the communication of regulatory information on medicinal products 04_M2:Electronic standards for communication of drug regulatory information (1,064KB) Koji SHOMOTO (Fresenius Carbi-Japan)
05_E2B(R3)IWG:Data items and message specifications for transmitting individual case safety reports (172KB) Manabu Inoue (MSD)
06_M8: Electronic application form (590KB) Taku Watanabe (NIH)
Trends in validity topics 07_E2C(R2)IWG:Periodic safety update report on marketed drugs (PBRER) (233KB) Yukiko Watanabe (Chugai Pharmaceutical)
08_E14 IWG: Clinical evaluation of QT/QTc interval prolongation and potential proarrhythmic effects in non-antiarrhythmic drugs (717KB) Tomonori ANDO (NIH)
Trends in Quality Topics 09_Q3D:Metallic impurities (622KB) Chikako YOMODA (NIH)
10_Q7IWG:GMP for active pharmaceutical ingredients (571KB) Masatoshi Morisue (NIH)
Trends in Safety Topics 11_S1:Carcinogenicity study (revised) (530KB) Mizuho Nonaka (NIH)
12_S10: Evaluation of photosafety (664KB) Dai Nakae (Tokyo Metropolitan Institute of Public Health)
13_M7: Evaluation and control of DNA-reactive (mutagenic) impurities (212KB) Tsuneo Hashizume (Takeda Pharmaceutical Company Limited)
14_Safety Brainstorming Session(256KB) Kazuichi Nakamura (Shionogi & Co., Ltd.)
 

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