ICHPharmaceutical Regulations in Japan

ICH Japan Symposium 2009
(The 20th ICH Public Meeting)

Since the ICH Steering Committee agreed to the organization of meetings focused on a regional basis at the Brussels Meeting in May 2007, regional ICH public meetings have been held in each ICH region; first in Tokyo on November 2, 2007, then the following year in the US and Europe. The meeting entitled “ICH Japan Symposium 2009” is the second regional ICH public meeting held in Japan which took place at the Tower Hall Funabori in Tokyo on June 12, 2009, the following day of the ICH Yokohama Meeting (June 6 - 11, 2009).

The Symposium aimed to provide an opportunity to update to the public on the progress made during the ICH meeting in Yokohama and on the status of the various ICH guidelines under development. It also aimed to provide an opportunity for participants and the ICH experts/rapporteurs to have a Q&A on a face-to-face basis on all the topics discussed at the Yokohama Meeting. In addition, the Symposium also had a special session on the implementation of ICH guidelines in Asian countries, with regulatory speakers mainly from Asian countries of the ICH Global Cooperation Group presenting on the use of ICH guidelines and on the value of training in helping to facilitate implementation. The Symposium was well attended with approximately 600 participants of the pharmaceutical industry, the regulatory authorities, etc. from the following 18 countries in Africa, Asia, Europe and North America; Botswana, Mozambique, China, Chinese Taipei, India, Korea, Singapore, Thailand, Austria, Belgium, France, Germany, Sweden, Switzerland, UK, Canada, USA and Japan. The participants had the opportunity to receive an update on the progress, to enhance the mutual understanding and to meet with regulators and industry experts from both ICH and non-ICH regions.

The Symposium was jointly organized by Japan Pharmaceutical Manufacturers Association (JPMA) and the Society of Japanese Pharmacopoeia (SJP, non-profit organization), and supported by the Ministry of Health, Labour and Welfare (MHLW), the Federation of Pharmaceutical Manufacturers’ Association of Japan, the Pharmaceutical Manufacturers’ Association of Tokyo, the Osaka Pharmaceutical Manufacturers Association and the Japan Pharmaceutical Association.

Working Language: Japanese/English
None of this publication may be reproduced by any means without the prior permission of the copyright owner.

Location: Tower Hall Funabori, Edogawa-ku, Tokyo, Japan
Date: June 12, 2009 10:00 a.m.-5:15 p.m.

Program: ICH Japan Symposium 2009 (PDF 67KB)
Proceedings of ICH Public Meeting: ICH Japan Symposium 2009(PDF 3M)

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