ICH Project ICH Japan Symposium 2012

June 15, 2012

ICH Japan Symposium 2012
(26th ICH Immediate Release Report)

As a forum for presentation and discussion of the outcomes of the ICH Fukuoka Meeting (June 2-7, 2012, Fukuoka, Japan), the fourth ICH regional meeting in the Japan region was held on July 25, 2012, at Tsuda Hall, Tokyo, Japan, under the title "ICH Japan Symposium 2012".

This symposium was held with the following contents. The symposium started with a general report on the history of ICH and the latest developments of ICH, followed by reports and Q&A sessions on almost all the ongoing topics in ICH, including electronic standards for communication of regulatory information, efficacy, safety, and quality, by experts from each Topic Working Group. The symposium was attended by approximately 300 participants.
The symposium was attended by approximately 300 participants, who showed a high level of interest in the topics, especially in the Q&A session on safety and quality, which led to a lively discussion.
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 place of the symposium

Date and Time Location
July 25, 2012 (Wednesday) 10:00-16:40 Tsuda Hall
1-18-24 Sendagaya, Shibuya-ku, Tokyo

Information, Program

Information / Program (337KB)

Presentation Materials

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Presentation Speakers
00_Opening Remarks (74KB) Kohei Wada (Daiichi Sankyo)
01. History of ICH (316KB) Naoyuki Yasuda (Ministry of Health, Labour and Welfare)
02. The latest trend of ICH (303KB) KURAJIRO KISHI (JPMA)
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 (1,667KB) Koji Shomoto (Bristol-Myers)
04_E2B (R3): Data items and message specifications for transmitting individual case safety reports (389KB) Ayumi Endo (Japan Health Sciences Agency)
05_M5: Data items and criteria for drug dictionary (968KB) Maiko Suzuki (NIHS)
06_M8 (eCTD): Electronic application form (539KB) Akiyo Fujikawa (Daiichi Sankyo)
Trends in Efficacy Topics 07_E2C(R2): Periodic safety update report on marketed drugs (PBRER) (646KB) Hazuki Takaura (Ministry of Health, Labour and Welfare)
08_E3 IWG: Structure and Contents of Summary Report of Clinical Trials Q&A (579KB) Kayo Shinohara (NIH)
09_E14 IWG: Clinical evaluation of QT prolongation and severe arrhythmia Q&A (180KB) Maki Ito (Shionogi)
Trends in Safety Topics 10_S1:Carcinogenicity study (review) (197KB) Shigeru Hisada (Asuka Pharmaceutical)
11_S10:Evaluation of photosafety (273KB) Dai Nakae (Tokyo Metropolitan Institute of Public Health)
12_M3(R2) IWG: Timing of Non-clinical Studies (Review) Q&A (1,130KB) Fumiro Sagami (Eisai)
13_M7: Genotoxicity Impurities (562KB) Shigeki Sawada (Sunplanet)
Trends in Quality Topics 14_Q3D:Metallic impurities (238KB) Masayuki MISHIMA (Chugai Pharmaceutical)
15_Q11:Development and Production of Active Pharmaceutical Ingredients (1,145KB) Kazunori TAKAGI (NIHS)
16_Quality brainstorming (153KB) Yoshihiro Matsuda (JAEA)
 

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