ICHPharmaceutical Regulations in Japan

Workshop on the ICH Q11 Guideline

Workshop on the ICH Q11 Guideline was held in Japan which took place at the Tower Hall Funabori, Edogawa-ku in Tokyo on August 5, 2011.

This workshop aimed to provide the explanation of ICH Q11, Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), and also it would enhance well-understood public consultation.
Approximately 400 participants from pharmaceutical industries attended this workshop and had vigorous Q&A 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. All the presentation used at the workshop 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: Tower Hall Funabori, 4-1-1, Funabori, Edogawa-ku, Tokyo, Japan
Date: August 5, 2011 10:00 a.m.-4:55 p.m.

Presentation materials Speakers
Session A: ICH Q11Guideline: Objective and Report of MHLW Study Group in the fiscal year 2010(PDF 1,515KB) Haruhiro Okuda, MHLW(NIHS)
Session B: ICH Q11Contents 01_ Manufacturing Process Development(PDF 802KB)
Case Study 1 Kazunori Takagi, MHLW (PMDA)
Case Study 2 Koji Takaki, JPMA
02_Selection of Starting Materials and Source Materials(PDF 940KB)
Case Study 4 Kiyotoshi Matsumura, JPMA
Case Study of MHLW Study Group Haruhiro Okuda, MHLW(NIHS)
03_Control Strategy Tsuyoshi Ando, MHLW(PMDA/Tokyo University)
04_Process Validation/Evaluation (Case Study 3)(PDF 980KB)
05_Submission of Manufacturing Process Development and Related Information in Common Technical Documents (CTD) Format and Lifecycle Management (Case Study5)(PDF 775KB) Tomonori Nakagawa, JPMA

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