ICH Project The 22nd ICH Public Meeting

July 15, 2010

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.

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  Presentation materials 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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