ICH Project ICH Japan Symposium 2009
Aug 24, 2009
The 4th ICH Public Meeting was held in Tokyo as ICH Japan Symposium 2009
The ICH Japan Symposium 2009 will be held in Yokohama, Japan in the fall of 2007, the day after the last day of the ICH Yokohama Meeting. The first official meeting was held in Tokyo on the day following the last day of the ICH Yokohama meeting in the fall of 2007, under the title of the ICH Tokyo Symposium. After regional meetings in the U.S. and Europe, the fourth ICH regional meeting (the second in the Japan region) was held on June 12, 2009, at Tower Hall Funabori in Funabori, Tokyo, under the title "ICH Japan Symposium 2009".
The symposium was attended by approximately 600 participants from 18 countries in Africa, Asia, Europe and North America (Botswana, Mozambique, China, Taiwan, India, Korea, Singapore, Thailand, Austria, Belgium, France, Germany, Sweden, UK, Canada, USA and Japan), including pharmaceutical regulatory authorities, pharmaceutical industry The symposium successfully concluded with the sharing of information on the outcomes of the ICH Yokohama meeting and the deepening of awareness on the efforts to implement the ICH Guidelines in the Asian region.
The ICH Japan Symposium 2009 was held with the following program. First, in Part I, presentations and discussions on the progress and results of the expert working groups at the Yokohama meeting were made as trends in each topic. In Part II, a panel discussion was held on ICH initiatives in Asian countries as part of the activities of the ICH International Cooperation Committee, which reports directly to the ICH Steering Committee.
In Part I, the history and future of ICH was presented as "History of ICH," followed by a summary of the progress and achievements of all the topics discussed at ICH as "Recent Trends in ICH. The progress and results of each topic were presented in sessions for each of the four areas (quality, safety, efficacy, and complex), where experts reported on their findings and engaged in lively discussions. Presentations were made by the ICH organizers, the Japanese, US, and EU pharmaceutical regulatory authorities (Japan: Ministry of Health, Labour and Welfare (MHLW); US: Food and Drug Administration (FDA); EU: European Commission (EC)) and industry associations (Japan: Japan Pharmaceutical Manufacturers Association (JPMA); US: US Pharmaceutical Research and Manufacturers of America (PhRMA); EU: European Federation of Pharmaceutical Industries and Associations (EFPIA)). This provided participants with a complete overview of the ICH Yokohama meeting and a better understanding of the content, progress, and future trends of each topic. At the same time, they had the opportunity to discuss each topic directly with experts from each country, which provided an opportunity to further deepen their understanding of the topics themselves.
In Part II, a panel discussion focused on ICH Guideline initiatives in Asian countries. Mr. Wada, Chairperson of the ICH Project Committee of the Japan Pharmaceutical Manufacturers Association (JPMA), chaired the discussion and gave a presentation on the history and efforts of the ICH International Cooperation Committee. Mr. Ward from the Ministry of Health and Welfare of Canada presented ICH training in non-ICH regions, Mr. Lim from the Singapore Health Sciences Board and Mr. Wong from the Taiwan Ministry of Health presented the current status of ICH initiatives in Singapore and Taiwan, respectively, and Mr. Wong from the Thai Ministry of Health and Welfare presented ICH training in Asian countries, including Thailand and South Korea. Mr. Jabrungrit from the Thai Ministry of Health and Mr. Kim from the Korean Institute of Toxicology presented on ICH training in Asian countries.
The program of this symposium (in English), the timetable of presentations (in Japanese), and the meeting record (Proceedings of ICH Public Meeting: ICH Japan Symposium 2009, in English) are attached as files below for your direct access.
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