ICH Project ICH Tokyo Symposium
Mar 31, 2008
ICH Tokyo Symposium, the first official ICH regional meeting, was held in Tokyo
Over 460 participants attended the symposium and it was a great success.
The ICH Tokyo Symposium, entitled "Hot Topics and Influence on Asia," was held on November 2, 2007, the day after the final day of the ICH Yokohama Meeting (ICH Steering Committee, Expert Working Groups and Implementation Working Groups Meeting) held from October 27 to November 1, 2007, at the Keidanren Hall in Tokyo's Chiyoda Ward. The meeting was held on November 2, 2007 at Keidanren Kaikan Hall in Chiyoda-ku, Tokyo. More than 460 pharmaceutical regulatory authorities and industry representatives from 13 countries in Europe, Asia and North America attended the meeting.
The ICH6 conference, held in Osaka in November 2003, was the sixth in a series of ICH conferences held every two to three years to present and discuss the results of the ICH project. As an alternative to the traditional ICH conferences, it was decided to hold smaller and more frequent ICH conferences in each of the regions of Japan, the U.S., and the EU. The first official ICH regional meeting was the ICH Tokyo Symposium held in Tokyo on November 2, 2007, the day after the last day of the ICH Yokohama meeting.
The ICH Tokyo Symposium was held with the following program. Opening remarks, report on the outcomes of the ICH Yokohama meeting held until the previous day, panel discussion on clinical development and ICH in Asia, and closing remarks.
In his opening remarks, ICH Project Chair Kohei Wada, on behalf of the host country, gave a welcome speech and described the background of the first ICH Regional Meeting, the significance of the meeting, its contents and future direction.
The session to report the outcome of the ICH Yokohama Meeting was designed as an immediate debriefing session to enhance the dissemination effect by reporting and presenting the results "immediately". First, the general results (Dr. Kishi, Pharmaceutical Manufacturers Association of Japan), the steering committee in general (Dr. Molzon, FDA), the hottest topic S2 (R2) genotoxicity study (review) (Dr. Hayashi, NIHS), periodic safety report of E2F development stage (Dr. Sato, NIHS), the guideline for drug product development (addendum) Q8 (R1) (Dr. Okuda, NIHS) The reports were presented by the rapporteurs or topic leaders, focusing on the following topics: Periodic Safety Reporting at the E2F Development Stage (Dr. Hayashi, NIH), Periodic Safety Reporting at the E2F Development Stage (Dr. Sato, NIH), Drug Development Guidelines (Addendum) Q8 (R1) (Dr. Okuda, NIH), Quality New Paradigm (Dr. Robert, EU), Communication of M2 Emergency Safety Information via Electronic Media (Dr. Ma, EFPIA), Timing (Review) of M3 (R2) Nonclinical Studies (Dr. De George, PhRMA) The panel discussion focused on clinical trials in Asia.
The panel discussion focused on clinical development in Asia, especially on the actual implementation of ICH guidelines in each country in the non-ICH region, with Mr. Ward from Health and Welfare Canada speaking from the perspective of the ICH International Cooperation Committee in general and Mr. Wada, Chair of the ICH Project Committee of the Pharmaceutical Manufacturers Association of Japan, from the perspective of industry, and International Cooperation Committee member Mr. Ding of China's SFDA, Mr. Kim of Korea's KFDA, and Mr. Jabrungrit of Thailand's FDA, who represented the RHIs, gave presentations on their countries' efforts, status, and problems in introducing GCP guidelines, and a general discussion was held at the end based on these presentations.
In his closing remarks, Mr. Toshima, Director of the Review Center of the Pharmaceuticals and Medical Devices Agency (PMDA), gave a summary of the first regional meeting.
The proceedings of this ICH Tokyo Symposium can be viewed directly in the file attached below.
Proceedings of ICH Tokyo Symposium: Hot Topics and Influence on Asia, Tokyo 2007（2.63MB)
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