The purpose of “East Asian Pharmaceutical Regulatory Symposium 2008”
Global drug development has accelerated in these days. Clinical trials which once were mainly conducted by Western countries have been shifting to multilateral and multicenter trials. The number of cases of global clinical trials has been rapidly increasing aimed to simultaneous global development and application in recent years. And also Asian countries have come to have an active involvement in these global clinical trials.
In Japan, there has been more interest in global clinical trials over the few years. PMDA makes clear its intention to encourage global clinical trials as a powerful card for eliminating an aggravated issue of Drug Lag.
The Health Ministers of China, Japan, and South Korea met in Soul, on April 8th 2007, discussed several issues of common concerns on Health and Medical field and built basic consensus for future cooperation. And also SFDA (China) and MHLW (Japan) are working together toward a further strengthening of their relations.
One of the themes of mutual cooperation is to enhance New Drug Development especially clinical development. Concretely, the initiative is to conduct Global Clinical Trials in East Asian Countries for the foreseeable future by accumulating the data on ethnic factors amongst the three countries. Furthermore it maps out strategies to realize speedy development and approval review using those data.
Under these circumstances, we hope this symposium will be very timely to serve as an opportunity to exchange opinions and to develop specific and effective cooperation for the future by gathering the representatives of regulatory authorities, pharmaceutical industry and academia from Japan, China, South Korea and other East Asian countries. We also expect it contribute to promote and advance clinical trials in East Asian region.
Organizing Committee
| Chairman : | Tatsuya Kondo, Chief Executive, PMDA |
| Vice Chairman : | Shuuichi Kishida, Senior Executive Director, PMDA |
| Member : | Kozo Yamada, Executive Director, PMDA |
| Member : | Satoshi Toyoshima, Executive Director and Director of Center for Product Evaluation, PMDA |
| Member : | Akira Kawahara, Chief Safety Officer, PMDA |
| Member : | Kazuhiko Mori, Associate Center Director, PMDA |
| Member : | Takenobu Inagawa, Director, Office of Planning and Coordination, PMDA |
| Member : | Toshiyoshi Tominaga, International Planning Director (Pharmaceutical Affairs), Minister's Secretariat, MHLW |
| Member : | Toshiro Nakagaki, Director, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW |
| Member : | Tsutomu Matsuda, Director, Safety Division, Pharmaceutical and Food Safety Bureau, MHLW |
| Member : | Nobuharu Kumamoto, Director, Compliance and Narcotic Division, Pharmaceutical and Food Safety Bureau, MHLW |
Program Committee
| Chairman : | Satoshi Toyoshima, Executive Director and Director of Center for Product Evaluation, PMDA |
| Member : | Kazuhiko Mori, Associate Center Director, PMDA |
| Member : | Kaoru Misawa, Director, Office of Safety, PMDA |
| Member : | Yuichi Shimmi, Director, Office of Compliance and Standards, PMDA |
| Member : | Yoshiaki Uyama, Review Director, Office of New Drug III, PMDA |
| Member : | Toshiyoshi Tominaga, International Planning Director (Pharmaceutical Affairs), Minister's Secretariat, MHLW |
| Member : | Kazuhiko Nakajima, Chanperson, Drug Evaluation Committee, JPMA |
| Member : | Masaru Iwasaki Chairperson, Technical Committee, EFPIA |
| Member : | Toshihiko Kobayashi, Japan Technical Representative, PhRMA |
Secretariat
| Director : | Takenobu Inagawa, Director, Office of Planning and Coordination, PMDA |
| Deputy Director : | Kyoichi Tadano, Director, International Affairs Division, PMDA |
| Member : | Takashi Nukada, Manager, Public Information Group, Office of Planning and Coordination, PMDA |
| Member : | Kanae Okamura, International Affairs Division, PMDA |
| Member : | Yoshitomo Shimizu, Deputy Director, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW |
| Member : | Takayuki Okubo, Section Chief, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW |
Pharmaceuticals and Medical Devices Agency
Ministry of Health, Labour and Welfare