| • Presented Powerpoint (in pdf) |
| Thu. October 12 |
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Chair: Mr. Shuuichi Kishida, Senior Executive Director, PMDA
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| 13:30～13:45 |
Opening Remarks
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Dr. Tatsuo Kurokawa, Councilor, Minister's Secretariat, MHLW (Japan)
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| 13:45～14:15 |
The Impact of Global Development: a US FDA Perspective
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Dr. Murray M. Lumpkin, Deputy Commissioner, FDA (USA)
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|
| 14:15～14:45 |
Global Development of Drugs and Co-operation among Asian Economies
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Dr. Chi-Chou Liao, |
Director General, Bureau of Pharmaceutical Affairs,
Department of Health (Chinese Taipei)
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|
| 14:45～15:15 |
Role of Japan and Asian Countries in the Global Pharmaceutical Development
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Mr. Akira Miyajima, Chief Executive, PMDA (Japan)
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|
| 15:15～15:45 |
Coffee Break |
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Chair: Mr. Akira Kawahara, Chief Safety Officer, PMDA
|
| 15:45～16:15 |
Recent Development of ICH GCG
| |
Dr. Minoru Kubota, Chairman, ICH Project Committee, JPMA (Japan)
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|
| 16:15～16:45 |
The Continuing History of the Safety of Medicines
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Prof. Sir Alasdair M. Breckenridge, Chairman, MHRA (UK)
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|
| 16:45～17:15 |
Combination Products and Asia Regional Medical Device Regulatory Harmonization
| |
Mr. Michael B. Gropp, |
Vice President, Global Regulatory and Public Policy,
Abbott Vascular, Brussels (Belgium)
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|
| 19:00～21:00 |
Reception |
|
| Fri. October 13 AM |
Session and Panel Discussion on Global Development in Asia
| |
Chair: Dr. Toshiyoshi Tominaga, |
International Planning Director (Pharmaceutical Affairs),
Minister's Secretariat, MHLW (Japan)
|
|
| 9:00～9:20 |
Global Development in Asia: a PhRMA Perspective
| |
Mr. Harrison C. Cook, Co-chair, JTC, PhRMA (USA)
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|
| 9:20～9:40 |
Global Develoment in Asia - a JPMA perspective -
| |
Mr. Hironobu Saito, |
Senior Vice Director, Clinical Development Department &
Asia Drug Development and Registration Section,
New Drug Development Division, Sankyo Co., Ltd. (Japan)
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|
| 9:40～10:00 |
Global Development in Asia: The Singapore Perspective
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Dr. John Lim, Chief Executive Officer, HSA (Singapore)
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|
| 10:00～10:20 |
Global Clinical Trials in Korea
| |
Dr. In-Sook Park, |
Deputy Director, Narcotic and Neuropharmacological
Drug Team, Department of Drug Evaluation, KFDA (Korea)
|
|
| 10:20～10:50 |
Coffee Break |
| 10:50～11:10 |
Global Development in Chinese Taipei
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Dr. Herng-der Chern, Executive Director, CDE (Chinese Taipei)
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|
| 11:10～11:30 |
Global Development: Japanese Efforts and Views
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Mr. Kazuhiko Mori, Associate Center Director, PMDA (Japan)
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|
| 11:30～12:20 |
Panel Discussion
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| Fri. October 13 PM |
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Chair: Dr. Satoshi Toyoshima, Executive Director, PMDA (Japan)
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| 14:20～14:50 |
EMEA's Views on Global Development
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Mr. Thomas Lönngren, Executive Director, European Medicines Agency (EMEA)
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|
| 14:50～15:20 |
ASEAN Harmonization
| |
Dr. Yuppadee Javroongrit, Thai FDA (Thailand)
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|
| 15:20～15:50 |
Coffee Break |
| 15:50～16:20 |
Expectations of Asian Collaboration and Contribution to New Medicines
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Mr. Kazuhiko Nakajima, Chairperson of Drug Evaluation committee, JPMA (Japan)
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|
| 16:20～16:50 |
Summary Report APEC 2006
| |
Dr. Satoshi Toyoshima, Executive Director, PMDA (Japan)
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|
| 16:50～17:00 |
Closing Remarks
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Mr. Toshiro Nakagaki, |
Director, Evaluation and Licensing Division,
Pharmaceutical and Food Safety Bureau, MHLW (Japan)
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