ICHPharmaceutical Regulations in Japan

ICH Tokyo Symposium 2007: Hot Topics and Influence on Asia
The First Regional ICH Public Meeting

Since the first International Conference on Harmonization (ICH 1) was held in Brussels, November 1991, following International Conferences had taken place to date; ICH 2 in Orland, USA, October 1993, ICH 3 in Yokohama, Japan, November 1995, ICH 4 in Brussels, Belgium, July 1997, ICH 5 in San Diego, USA, November 2000 and ICH 6 in Osaka, Japan, November 2003.

Instead of continuing this practice, the Steering Committee (SC) re-considered the need to organize a large scale public conference and it was recommended that other educational models should be explored for the communication about ICH. An Options Paper on the need for a large scale public conference was drafted by three industry associations. Out of the several options raised, the one to hold smaller, more frequent and more focused ICH meetings was supported by the SC in Chicago Meeting 2006; hence ICH 6 became the last conference of the traditional large scale. Further to refine this option, the ICH Industry Party Implementation Paper for the ICH public conferences was presented at the Brussels SC Meeting 2007. Here, principles such as size, organization, frequency, format, financial aspects of the meeting and evaluation process were clarified. It was judged appropriate that the conference should be held every eighteen months in each ICH region, either as a one-day additional communication meeting at the end of ICH SC and EWG/IWG meetings, or as an ICH-branded regional meeting in collaboration with other non-profit organizations.

Based on the SC decision, the ICH Tokyo Symposium titled "Hot Topics and Influence on Asia" was held in Tokyo on November 2, 2007, the following day of the ICH Yokohama Meeting (October 27 to November 1, 2007), as the first regional ICH public meeting. The Symposium was jointly organized by the Society of Japanese Pharmacopoeia (SJP, non-profit organization) and Japan Pharmaceutical Manufacturers Association (JPMA) and supported by the Ministry of Health, Labour and Welfare (MHLW), Federation of Pharmaceutical Manufacturers' Association of Japan, Pharmaceutical Manufacturers' Association of Tokyo, Osaka Pharmaceutical Manufacturers Association and Japan Pharmaceutical Association. Over 460 participants from the pharmaceutical industry and the regulatory authorities of Europe, Asia and North America (13 countries; France, Luxembourg, Netherlands, Switzerland, UK, Turkey, Thailand, China, Korea, Singapore, Japan, Canada and USA) attended the Symposium.

Working Language: Japanese/English
None of this publication may be reproduced by any means without the prior permission of the copyright owner.
Location: Keidanren Hall, Tokyo, Japan
Date: November 2, 2007

Program: ICH Tokyo Symposium 2007 (PDF 211KB)
Proceedings: ICH Tokyo Symposium 2007 (PDF 2.63MB)

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