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 |