ICHPharmaceutical Regulations in Japan

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

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.

Program: Integrated Implementation Training Workshop on ICH Q8/Q9/Q10 Points to Consider(PDF 52KB)

Presentation materials Speakers
00_Welcoming Address Hironobu Saito, JPMA
01_Introduction(PDF 409KB) Fusashi Ishikawa, JPMA
02_Criticality of Quality Attributes and Process Parameters(PDF 825KB) Yukio Hiyama, MHLW(NIHS)
03_Control Strategy(PDF 591KB) Tetsuhito Takarada, JPMA
04_Level of Documentation in Enhanced (QbD) Regulatory Submission(PDF 674KB) Yoshihiro Matsuda,MHLW(PMDA)
05_Role of Models in Quality by Design (QbD)(PDF 488KB) Fusashi Ishikawa, JPMA
06_Design Space(PDF 658KB) Kazuhiro Okochi, JPMA
07_Process Validation / Continuous Process Verification(PDF 654KB) Masatoshi Morisue, MHLW(PMDA)
08_Background and Issues about Revised Enforcement Notice on Good Manufacturing Products(PDF 1409KB) Masatoshi Morisue,MHLW(PMDA)
09_Consideration of the Case Study for Sakuramil(PDF 1600KB) Kazunori Takagi,MHLW(PMDA)

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