ICH Project ICH Japan Symposium 2013

December 24, 2013

ICH Japan Symposium 2013
(29th ICH Public Meeting)

The ICH Regular Meeting was recently held in Osaka from November 9 to 14, 2013.To share information on ICH developments with the general public, including representatives from companies responsible for drug development and safety assurance, we held the ICH Japan Symposium 2013 (29th ICH Public Meeting) as the official ICH meeting for the Japan region on December 10, 2013, at Tsuda Hall in Tokyo.

At this symposium, following a general report on the latest ICH trends, experts from the respective topic working groups presented reports and held Q&A sessions on electronic standards for the transmission of pharmaceutical regulatory information, as well as trends in topics related to efficacy, safety, and quality.

Approximately 200 participants attended the symposium. Under the moderation of the chairs for each topic, lively discussions took place—particularly regarding trends in safety—demonstrating the high level of interest among attendees.
The program, schedule of presentations, and presentation materials for this symposium are attached below and can be viewed directly.
Please note that unauthorized copying or reproduction of the attached materials is prohibited.

Date, Time, and Venue

Date and Time Location
Tuesday, December 10, 2013, 10:00 a.m.–4:40 p.m. Tsuda Hall
1-18-24 Sendagaya, Shibuya-ku, Tokyo

Information and Program

Event 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, Labor and Welfare)
03_Latest ICH Developments (265KB) Kurajiro Kishi (JPMA)
Trends in Topics Related to Electronic Standards for the Transmission of Pharmaceutical Regulatory Information 04_M2: Electronic Standardization for the Transmission of Pharmaceutical Regulatory Information (1,064KB) Koji Shomoto (Fresenius Kabi Japan)
05_E2B (R3) IWG: Data Elements and Message Specifications for the Transmission of Individual Case Safety Reports (172KB) Manabu Inoue (MSD)
06_M8: Electronic Application Forms (590 KB) Taku Watanabe (NIH)
Trends in Topics Related to Efficacy 07_E2C (R2) IWG: Periodic Safety Update Report (PBRER) for Over-the-Counter Drugs (233 KB) Yukiko Watanabe (Chugai Pharmaceutical)
08_E14 IWG: Clinical Evaluation of QT/QTc Interval Prolongation and Potential Arrhythmogenicity in Non-Antiarrhythmic Drugs (717KB) Yuki Ando (NIH)
Trends in Quality-Related Topics 09_Q3D: Metallic Impurities (622KB) Chikako Shikata (NIH)
10_Q7IWG: Active Pharmaceutical Ingredient (API) GMP (571 KB) Masatoshi Morisue (NIH)
Trends in Safety-Related Topics 11_S1: Carcinogenicity Testing (Revised) (530KB) Mizuho Nonaka (NIH)
12_S10: Evaluation of Phototoxicity (664KB) Hiroshi Nakae (Tokyo Metropolitan Institute of Public Health)
13_M7: Evaluation and Control of DNA-Reactive (Mutagenic) Impurities (212KB) Tsuneo Hashizume (Takeda Pharmaceutical Company)
14_Safety Brainstorming Session (256 KB) Kazushi Nakamura (Shionogi & Co., Ltd.)
 

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