ICH Project The 24th ICH Public Meeting

July 20, 2011

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.

Side-scrollable

  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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