Globalization of development, manufacturing, trade, and marketing of pharmaceutical drugs has been progressing, and cooperation of regulatory activities amongst pharmaceutical regulatory agencies of each region has become a necessity. Nowadays, Asian countries have become significant in clinical development and manufacturing of drugs globally, and therefore, the collaborative relationship among the Asian regulatory agencies is becoming highly important. This symposium is the joint conference hosted by East Asia Relations Commission and Interchange Association, Japan, with the aim to enhance mutual understandings, and to construct a basis in a cooperative system across the region for further development in pharmaceutical regulations and health insurance system under the MOU of 5 items signed between Taiwan and Japan on 5th November 2013. In the 4th symposium, most recent information on pharmaceutical regulations of drugs and medical devices based on regulatory science, and on national health insurance system will be shared, and safety management and quality control of medical products will be focused in the discussion.
Taipei Economic and Cultural Representative Office in Japan
Interchange Association, Japan
Support:
Pharmaceuticals and Medical Devices Agency
Taiwan Food and Drug Administration
Center for Drug Evaluation
【Pharmaceuticals Associations】
Japan Pharmaceutical Manufacturers Association (JPMA)
Japanese Chamber of Commerce & Industry Taipei
Taiwan Pharmaceutical Manufacturers Association
Taiwan Research-based Pharmaceuticals Manufactures Association
International Research-based Pharmaceutical Manufacturers Association
Taiwan Generic Pharmaceutical Association
Chinese Pharmaceutical Manufacture and Development Association
Japan Self-Medication Industry
Asia-Pacific Self-Medication Industry
【Medical Devices Associations】
Japan Federation of Medical Devices Associations (JFMDA)
Taiwan Medical and Biotech Industry Association
Taiwan Federation of Medical Device Commercial Associations
December 7, 2016
Joint session and pharmaceuticals session
Nihonbashi Life Science HUB 8F,
1-5-5, Nihonbashi-muromachi, Chuo-ku, Tokyo
Medical devices session
Nihonbashi Life Science Bldg. 10F
2-3-11, Nihonbashi-honcho, Chuo-ku, Tokyo
TEL: 03-6214-3086
URL: https://www.nihonbashi-lifescience.jp/#
Simultaneous translation will be provided for Japanese and Chinese.
Joint Session | |
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08:30-09:00 | Registration |
09:00-09:30 | Opening Remarks |
Mr. Hitoshi Funamachi, Senior Executive Director, Interchange Association, Japan | |
Mr. Hou-Chun CHANG, Director, Economic Division, Taipei Economic and Cultural Representative Office in Japan | |
Mr. Kazuhiko Mori, Councilor, MHLW | |
Dr. Shiow-Ing Wu, Deputy Director-General, TFDA | |
Mr. Tadaharu Goto, Director General, JPMA | |
Mr. Tung-Mao Su, Standing Director, Taiwan Pharmaceutical Manufacturer’s Association | |
Mr. Koji Nakao, President, JFMDA | |
Mr. Chi-Chung Huang, Chairman, Taiwan Medical and Biotech Industry Association | |
09:30-09:40 | Memorial Photo Taking |
09:40-10:40 | Moderator: Mr. Yoshihiko Sano (MHLW) Regulatory Updates for Medical Products in Japan and Taiwan) |
10:40-10:55 | Coffee Break |
Parallel Session (Pharmaceuticals) | |
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10:55-11:55 | Moderator: Ms. Chao-Yi Wang (TFDA) WGs Progress Report
Panel Discussion (20min) |
11:55-13:00 | Luncheon |
13:00-13:50 | Moderator: Mr. Naoyuki Yasuda (PMDA)
Panel Discussion (10min) |
13: 50-15:05 | Moderator: Dr. Churn-Shiouh Gau (CDE)
Panel Discussion (10min) |
15:05-15:20 | Coffee Break |
15:20-16:20 | Moderator: Mr. Yoshihiko Sano (MHLW)
Panel Discussion (15min) |
Parallel Session (Health Insurance) | |
16:20-17:20 | Moderator: Mr. Yoshihiko Sano (MHLW) Update on regulations in NHI pricing and related policy
Panel discussion (20min) |
Pharmaceuticals &Health Insurance | |
17:20-17:30 | Closing Remarks
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18:00- | Welcome Reception (Nihonbashi Life Science Bldg. 10F) |
Parallel Session (Medical Devices) | |
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11:15-11:45 | Moderator: Ms. Yumiko Aoyagi (MHLW)
Panel Discussion (15min) |
11:45-13:15 | Luncheon |
13:15-13:45 | Moderator: Ms. Yumiko Aoyagi (MHLW)
Panel Discussion (15min) |
13:45-15:30 | Moderator: Mr. Ming-Shin Lee, Director, Division of Risk Management, (TFDA)
Panel Discussion (25min) |
15:30-15:40 | Closing Remarks
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15:40-16:00 | Coffee Break |
16:00-17:30 | Closed Meeting
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18:00- | Welcome Reception (Nihonbashi Life Science Bldg. 10F) |