ICH Project ICH Japan Symposium 2013
Dec 24, 2013
ICH Japan Symposium 2013
(29th ICH Instantaneous Reporting Session)
Recently, the ICH Regular Meeting was held in Osaka, Japan, November 9-14, 2013. In order 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 Immediate Report Meeting 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.
The contents of the attached materials may not be copied or reproduced without prior permission.
Date, time and place
| Date and Time | Location |
|---|---|
| Tuesday, December 10, 2013, 10:00-16:40 | Tsuda Hall
1-18-24 Sendagaya, Shibuya-ku, Tokyo |
Information and Program
Presentation materials
Horizontal scrolling is available
| Presentation | Speaker | |
|---|---|---|
| 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 (Pharmaceutical Manufacturers Association of Japan) | |
| Trends in Topics on Electronic Standards for Communication of Drug Regulatory Information | 04_M2：Electronic standardization 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 Efficacy Topics | 07_E2C(R2) IWG: Periodic safety update report (PBRER) on marketed drugs (233KB) | Yukiko Watanabe (Chugai Pharmaceutical) |
| 08_E14 IWG: Clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects of Non-Antiarrhythmic Drugs (717KB) | Yuki Watanabe（Chugai Pharmaceutical Co.) | |
| Trends in Quality Topics | 09_Q3D：Metallic Impurities (622KB) | Chikako Yomota（National Institute for Advancement of Science and Technology) |
| 10_Q7IWG：GMP for active pharmaceutical ingredients (571KB) | Masatoshi Morisue (NIH) | |
| Trends in Safety Topics | 11_S1: Carcinogenicity study (revised) (530KB) | Mizuho Nonaka（National Institute for Health Sciences) |
| 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) |
The End