ICH Project The 28th ICH Public Meeting
July 26, 2013
The 28th ICH Public Meeting was held in Japan which took place at the Tsuda Hall, Shibuya-ku in Tokyo, on July 26, 2013.This Public Meeting aimed to provide an opportunity to give the public updated information on the progress made during the ICH Meeting in Brussels from June 1-6, 2013, 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.
All the presentation used in the meeting is available in Japanese as below.
- Working Language
- Japanese
- Simultaneous English-Japanese Translation
- Not Available
None of this publication may be reproduced by any means without the prior permission of the copyright owner.
- Location
- Tsuda Hall, 1-18-24, Sendagaya Shibuya-ku, Tokyo, Japan
- Date
- July 26, 2013 10:00 a.m. -4:00 p.m.
Program: 28th ICH Public Meeting (36KB)
Side-scrollable
| Presentation materials | Speakers | |
|---|---|---|
|
|
01_ Future of ICH (193KB) |
Hironobu Saito, JPMA |
| 02_ Overview of ICH Topics-General Update on ICH (262KB) |
Kurajiro Kishi, JPMA |
|
|
Topics for the Electronic Exchange of Information |
03_ E2B (R3): Electronic Submission in Individual Case Safety Reports (ICSRs)(567KB) |
Ayumi Endo, MHLW(PMDA) |
| 04_ M8: The Electronic Common Technical Document: eCTD (662 KB) |
Akiyo Fujikawa, JPMA |
|
|
Safety Topics |
05_ S1: Rodent Carcinogenicity Studies for Human Pharmaceuticals(540KB) |
Shigeru Hisada, JPMA |
| 06_ S10: Photosafety Evaluation(1,313KB) |
Dai Nakae, MHLW(TMIPH) |
|
|
Quality Topics |
07_ Q3D: Guideline for Elemental Impurities(1,119KB) |
Masayuki Mishima, JPMA |
| 08_ Q7:Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (710KB) |
Tetsuhito Takarada, JPMA |