ICH Project Integrated Implementation Training Workshop on ICH Q8/Q9/Q10 Points to Consider

February 15, 2013

Integrated Implementation Training Workshop on Q8/Q9/Q10 Points to Consider was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on February 15, 2013.
This workshop was the first opportunity to provide the explanation of ICH Q8/Q9/Q10 Points to Consider to the public. This Points to Consider has an important role to clarify the interpretation of the guideline for ICH Q8/Q9/Q10 and also closely related to the revision of enforcement notice on GMP. In order to facilitate interpretation and implementation of those guidelines, the workshop included the lecture of the Points to Consider, presentation regarding the introduction to Japan, case study and panel discussion.
The workshop 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, the Osaka Pharmaceutical Manufacturers Association and the Japan Pharmaceutical Association and Japan Bulk Pharmaceutical Manufacturers Association. All the information as well as the presentation used at the symposium in Japanese is available 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
Zendentsu Hall, 3-6, Kandasurugadai, Chiyoda-ku, Tokyo, Japan
Date
February 15, 2013 10:00 a.m.-5:00 p.m.
Presentation materials Speakers
00_Welcoming Address Hironobu Saito, JPMA
01_Introduction(409KB) Fusashi Ishikawa, JPMA
02_Criticality of Quality Attributes and Process Parameters(825KB) Yukio Hiyama, MHLW(NIHS)
03_Control Strategy(591KB) Tetsuhito Takarada, JPMA
04_Level of Documentation in Enhanced (QbD) Regulatory Submission(674KB) Yoshihiro Matsuda,MHLW(PMDA)
05_Role of Models in Quality by Design (QbD)(488KB) Fusashi Ishikawa, JPMA
06_Design Space(658KB) Kazuhiro Okochi, JPMA
07_Process Validation / Continuous Process Verification(654KB) Masatoshi Morisue, MHLW(PMDA)
08_Background and Issues about Revised Enforcement Notice on Good Manufacturing Products(1409KB) Masatoshi Morisue,MHLW(PMDA)
09_Consideration of the Case Study for Sakuramil(1600KB) Kazunori Takagi,MHLW(PMDA)

share