ICH Project ICH Japan Symposium 2012

Jun 15, 2012

ICH Japan Symposium 2012
(The 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, 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.
Please note that the contents of the attached materials may not be copied or reproduced without prior permission.

Date, time and place

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

Information and Program

Information / Program (337KB)

Presentation materials

Horizontal scrolling is available

  Presentation Speaker
  00_Opening Remarks(74KB) Kouhei Wada (Daiichi Sankyo)
01_ICH History (316KB) Naoyuki Yasuda (Ministry of Health, Labour and Welfare)
02_ICH Latest Trends (303KB) Kurajiro Kishi (Pharmaceutical Manufacturers Association of Japan)
Trends in Topics on Electronic Standards for Communication of Drug Regulatory Information 03_M2: Electronic Standardization for Communication of Regulatory Information on Medicinal Products (1,667KB) Koji SHOMOTO (Bristol-Myers)
04_E2B (R3): Data items and message specifications for transmitting individual case safety reports (389KB) Ayumi Endo (NIH)
05_M5: Data items and standards for drug dictionaries (968KB) Maiko SUZUKI (NIHO)
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 the Summary Report of Clinical Trials Q&A (579KB) Kayo Shinohara (NIH)
09_E14 IWG: Clinical evaluation of QT prolongation and serious arrhythmias Q&A (180KB) Maki Ito (Shionogi)
Trends in Safety Topics 10_S1:Carcinogenicity study (review) (197KB) Shigeru Hisada (Asuka Pharmaceuticals)
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: Genotoxic impurities (562KB) Shigeki Sawada (Sun Planet)
Trends in Quality Topics 14_Q3D: Metal impurities (238KB) Masayuki Mishima (Chugai Pharmaceutical)
15_Q11: Development and Manufacturing of Active Pharmaceutical Ingredients (1,145KB) Kazunori Takagi (General Pharmaceuticals Organization of Japan)
16_Quality Brainstorming (153KB) Yoshihiro MATSUDA (National Institute for Health Sciences)

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