ICH Project The 19th ICH Public Meeting
December 16, 2008
The 19th ICH Public Meeting was held in Japan which took place at the Komaba Eminence, Meguro-ku in Tokyo on December 16, 2008.This Public Meeting aimed to provide an opportunity to give the public updated information on the progress made during the ICH Meeting in Brussels in November 2008, and on the status of the various ICH Guidelines under development with a follow-up Q & A session.
- Working Language
- Japanese
- Simultaneous English-Japanese Translation
- Not Available
- Location
- Komaba Eminence, 2-19-5, Ohashi Meguro-ku, Tokyo, Japan
- Date
- December 16, 2008
Side-scrollable
| Presentation materials | Speakers | |
|---|---|---|
|
|
01_ Overview of ICH Topics |
Takayuki Okubo, MHLW |
|
Topics for the Electronic Exchange of Information |
02_ M2:Electronic Standards for the Transfer of Regulatory Information, eCTD |
Yasuhiro Araki, MHLW(PMDA) |
|
Efficacy Topics |
03_E16:Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions |
Sanae Yasuda, JPMA |
|
|
04_ GTDG: Gene Therapy Discussion Group |
Wataru Toriumi, JPMA |
|
Safety Topic |
05_ S6(R1):Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals |
Kazushige Maki, MHLW(PMDA) |
|
06_S9:Nonclinical Evaluation for Anticancer Pharmaceuticals |
Shuichi Kai, JPMA |
|
|
Quality Topics |
08_ Q4B(Annex):Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions |
Tsuneo Okubo, JPMA |
|
09_Q8(R1):Pharmaceutical Development |
Yasuhiro Okuda, MHLW(NIHS) |