ICHPharmaceutical Regulations in Japan

Integrated Implementation Training Workshop for ICH Q8, Q9, Q10: Follow-up

Integrated Implementation Training Workshop for ICH Q8, Q9, Q10: Follow-up was held in Japan at the Tower Hall Funabori, Edogawa-ku in Tokyo on April 25, 2011.

This follow-up training was aimed as a second opportunity to provide comprehensive information for the participants those who could not attend the first integrated implementation training workshop for ICH Q8, Q9 and Q10 in October 2010.

Over 330 participants from pharmaceutical industries and relevant industries attended this workshop and had vigorous Q&A discussion especially at the panel discussion on session D.

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: April 25, 2011 10:00 a.m.-5:05 p.m.
Program: Integrated Implementation Training Workshop for ICH Q8, Q9, Q10: Follow-up (PDF 61KB)

  Presentation materials Speakers
Session A:Integrated Implementation Training 01_Integrated Implementation Training Workshops for ICH Q8, Q9, Q10 Guidelines, Oct 25-27, 2010 in Tokyo: Objectives, Outcomes and Future(PDF 587KB) Yukio Hiyama, MHLW(NIHS)
Workshops for ICH Q8, Q9, Q10 Guidelines, Oct 25-27, 2010 in Tokyo: Objectives, Outcomes and Future    
Session B:How Q8, Q9, Q10 guidelines work in life cycle approach 02_Case Study: Product Development(PDF 737KB) Kazuhiro Okochi, JPMA
03_Case Study: Regulatory Assessment(PDF 722KB) Yoshihiro Matsuda MHLW(PMDA)
04_Case study: Implementation and Pharmaceutical Quality System considerations(PDF 818KB) Shigeki Tamura, JPMA
05_ Case study: Inspections at Manufacturing Site(PDF 584KB) Masatoshi Morisue, MHLW(PMDA)
Session C: Report from breakout session, Integrated Implementation Workshops for ICH Q8, Q9, Q10 Guidelines, Oct 25-27, 2010 in Tokyo 06_General Update:(PDF 462KB) Fusashi Ishikawa, JPMA
07_Design Space(PDF 254KB) Kimiya Okazaki, JPMA
08_Control Strategy(PDF 289KB) Takeshi Hamaura, JPMA
09_Pharmaceutical Quality Systems(PDF 283KB) Tomonori Nakagawa, JPMA
10_Quality Risk Managements(PDF 724KB) Kazunori Takagi, MHLW(PMDA)

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