ICHPharmaceutical Regulations in Japan

The 22nd ICH Public Meeting

The 22nd ICH Public Meeting was held in Japan which took place at the Tsuda Hall, Shibuya-ku in Tokyo on July 15, 2010.This Public Meeting aimed to provide an opportunity to give the public updated information on the progress made during the ICH Meeting in Tallin in June, 2010, 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 Society of Japanese Pharmacopoeia (SJP, 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 15, 2010 10:00 a.m. -4:00 p.m.

  Presentation Speakers
01_Welcoming Address Kohei Wada, JPMA
02_ Overview of ICH Topics Kurajiro Kishi, JPMA
Safety Topics 03_ S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Yoko Hirabayashi, MHLW(NIHS)
Topics for the Electronic Exchange of Information 04_ M2/M5:Electronic Standards for the Transfer of Regulatory Information, Data Elements and Standards for Drug Dictionaries Yoshihiko Inazumi, MHLW(PMDA)
05_ E2B(R3): Electronic Submission in Individual Case Safety Reports Ayumi Endo, MHLW(PMDA)
Efficacy Topics 06_ E2F:Development Safety Update Report Noriko Akagi, JPMA
07_E7(R1): Studies in Support of Special Populations: Geriatrics Yasuhiko Imai, JPMA
Quality Topics 08_ Q-IWG: Quality Implementation Working Group Yoshihiro Matsuda, MHLW(PMDA)
09_Q11:Development and Manufacture of Drug Substances(Chemical Entities and Biotechnological/Biological Entities) Koji Takaki, JPMA

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