ICHPharmaceutical Regulations in Japan

The 24th ICH Public Meeting

The 24th ICH Public Meeting was held in Japan which took place at the Tsuda Hall, Shibuya-ku in Tokyo on July 20, 2011. This Public Meeting aimed to provide an opportunity to give the public updated information on the progress made during the ICH Meeting in Cincinnati in June, 2011, and on the status of the various ICH Guidelines under development with a follow-up Q & A session.

The public meeting was jointly organized by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ, non-profit organization), and supported by the Federation of Pharmaceutical Manufacturers' Associations of Japan, the Pharmaceutical Manufacturers' Association of Tokyo, Osaka Pharmaceutical Manufacturers Association and Japan Pharmaceutical Association.

Working Language: Japanese
Simultaneous English-Japanese Translation: Not Available

Location: Tsuda Hall, 1-18-24, Sendagaya, Shibuya-ku Tokyo, Japan
Date: July 20, 2011 10:00 a.m. -4:00 p.m.

  Presentation materials Speakers
01_Welcoming Address Kohei Wada, JPMA
02_Overview of ICH Topics Kurajiro Kishi, JPMA
Safety Topics 03_S10: Photosafety Evaluation Kazuichi Nakamura, JPMA
04_M7: Assessment and Control of DNA Reactive(Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Yukio Aso, MHLW(PMDA)
Efficacy Topic 05_E2C(R2): Clinical Safety Data Management; Periodic Benefit-Risk Evaluation Report (PBRER) Yoko Hattori, JPMA
Topics for the Electronic Exchange of Informations 06_M5: Data Elements and Standards for Drug Dictionaries Izumi Oba, MHLW(PMDA)
07_E2B(R3): Revision of the Electronic Submission in Individual Case Safety Reports Miyako Shionoiri, JPMA
Quality Topics 08_Q3D: Guideline for Metal Impurities Masayuki Mishima, JPMA
09_Q11: Development and Manufacture of Drug Substances(Chemical Entities and Biotechnological/Biological Entities) Kazunori Takagi, JPMA

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