| Mon. April 14 | |
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Chair: Mr. Shuuichi Kishida, Senior Executive Director, PMDA (Japan)
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| 13:30-13:40 | Opening Remarks
Dr. Tatsuya Kondo, Chief Executive, PMDA (Japan) |
| 13:40-14:00 | Report for the Director-General level Meeting on the tripartite project on Clinical research
Dr. Toshiyoshi Tominaga, International Planning Director (Pharmaceutical Affairs), Minister's Secretariat, MHLW (Japan) |
| 14:00-14:30 | Global Development: China's perspective and the Role of SFDA
Mr. Zhang Wei, Director General Department of Drug Registration, SFDA (China) |
| 14:30-15:00 | Global Development: Korea's perspective and the Role of KFDA
Dr. Young-Chan, Kim, Director General, Pharmaceuticals Headquarters, KFDA (Korea) |
| 15:00-15:30 | Global Development: Japan's perspective and the Role of MHLW
Dr. Tatsuo Kurokawa, Councilor, Minister's Secretariat, MHLW (Japan) |
| 15:30-16:00 | Coffee Break |
| Mon. April 14: Session 1 | |
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Purpose: As pharmaceutical production and distribution became global, this session will focus on current status regarding standards, inspection practices and industry performance relative to GMP in the three countries for future collaboration in the region.
Chair: Dr. Yukio Hiyama, Section Manager, Division of Drugs,
National Institute of Health Sciences (Japan) |
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| 16:00-16:30 | Latest Trend of Drug Quality / GMP in Korea
Dr. In-Kyu, Kim, Director, Chemistry & Cardiovascular Team, |
| 16:30-17:00 | Latest Trend of Drug Quality / GMP in Japan
Mr. Shingou Sakurai, Director for GMP Inspection, Office of Compliance and Standards, PMDA (Japan) |
| 17:00-17:30 | Latest Trend of Drug Quality / GMP in China
Ms. Li Jinju, Consultant Department of Drug Safety Inspection, SFDA (China) |
| 17:30-18:00 | Panel Discussion
Panelists: Dr. In-Kyu, Kim, Ms. Zhang Yanli, Mr. Shingou Sakurai |
| Mon. April 14: Session 2 | |
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Purpose: The post marketing safety measures are becoming more and more importance with the progress of simultaneous world-wide development and the emergence of innovative biopharmaceuticals. This session will discuss the current status of and the possible cooperation in the post-marketing safety measures in the three countries with a view to ensuring appropriate use of new drugs.
Chair: Mr. Kaoru Misawa, Director, Office of Safety, PMDA (Japan)
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| 16:00-16:30 | Post-Marketing Safety Measures in China
Ms. Li Jinju, Consultant Department of Drug Safety Inspection, SFDA (China) |
| 16:30-17:00 | Post-Marketing Safety Measures in Korea
Dr. Joon-Su, Shin, Deputy Director, Pharmaceutical Management Team, KFDA (Korea) |
| 17:00-17:30 | Post-Marketing Safety Measures in Japan
Mr. Akira Kawahara, Chief Safety Officer, PMDA (Japan) |
| 17:30-18:00 | Panel Discussion
Panelists: Ms. Li Jinju, Dr. Joon-Su, Shin, Mr. Akira Kawahara |
| Mon. April 14: Reception | |
| 18:15-20:15 | Reception |
| Tue. April 15 AM | |
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Purpose: As part of simultaneous and worldwide drug development strategies, China, Korea and Japan have all begun to take part in Global Clinical Trials in these days.
The purposes of this session are to introduce the perspectives of pharmaceutical industries and regulators and to discuss the possibility of mutual cooperation toward the progress of drug development in the East Asian region. Chair: Mr. Kazuhiko Mori, Associate Center Director, PMDA (Japan)
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| 9:30-10:00 | Global Clinical Trial and Development: JPMA's Perspective
Mr. Hidetoshi Shuto, Corporate Officer / Vice President, Clinical Development I, Development Astellas Pharma Inc. (Japan) |
| 10:00-10:30 | Global Clinical Trial and Development: PhRMA's Perspective
Dr. Timothy R. Franson, Vice President for Global Regulatory Affairs Operational Committee Member, Eli Lilly (USA) |
| 10:30-11:00 | Global Clinical Trial and Development: EFPIA's Perspective
Dr. Tsutae Den Nagata, Director General, EFPIA Japan |
| 11:00-11:30 | Coffee Break |
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Global Clinical Trial and Development / Regulator's View I
Chair: Mr. Kazuhiko Mori, Associate Center Director, PMDA (Japan)
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| 11:30-12:00 | Review Policies for Global Drug Development: Singapore's Perspective
Dr. Christina LIM, Administrator, Health Products Regulation Group, Senior Advisor, International Collaboration, HSA (Singapore) |
| 12:00-12:30 | Review Policies for Global Drug Development: Thailand's Perspective
Dr. Yuppadee Javroongrit, Assistant Director & Head of International Affairs & IND Section, Food and Drug Administration, |
| 12:30-13:40 | Lunch |
| Tue. April 15 PM | |
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Global Clinical Trial and Development / Regulator's View II
Chair: Dr. Toshiyoshi Tominaga, International Planning Director
(Pharmaceutical Affairs), Minister's Secretariat, MHLW (Japan) |
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| 13:40-14:10 | Review Policies for Global Drug Development: Korea's Perspective
Mr. In-Beom, Kim, Deputy Director, Pharmaceutical Safety Policy Team, KFDA (Korea) |
| 14:10-14:40 | Review Policies for Global Drug Development: China's Perspective
Mr. Feng Yi, Chief of Office, Center for Drug evaluation, SFDA (China) |
| 14:40-15:10 | Review Policies for Global Drug Development: Japan's Perspective
Mr. Kazuhiko Mori, Associate Center Director, PMDA (Japan) |
| 15:10-15:30 | Japan's Study Group on Ethnic Factors in Clinical Data: Purpose and Current State
Dr. Masahiro Tokin, Section Manager, Division of Medical Safety Science, National Institute of Health Sciences (Japan) |
| 15:30-16:00 | Coffee Break |
| 16:00-17:30 | Panel Discussion
Panelists: Mr. In-Beom, Kim, Mr. Feng Yi, Mr. Kazuhiko Mori, Dr. Christina LIM, Dr. Yuppadee Javroongrit |
| 17:30-17:40 | Short Break |
| 17:40-18:00 | Summary Report
Dr. Satoshi Toyoshima, Executive Director, PMDA (Japan) |
| 18:00-18:10 | Closing Remarks
Mr. Toshiro Nakagaki, Director, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW (Japan) |
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Pharmaceuticals and Medical Devices Agency
Ministry of Health, Labour and Welfare
Secretariat of EAPRS 2008 PH (c/o Japan Convention Services, Inc.)
Tel:+81-3-3508-1243 Fax:+81-3-3508-1703 E-mail:eaprs08ph@convention.co.jp