18th October, 2017
Updated 7th Decemeber, 2017
Updated 22th Decemeber, 2017
Updated 26th Decemeber, 2017
Phrmaceuticals and Medical Devices Agency(PMDA)
The 5th Joint Cnference has been concluded. Thank you for participating.
Presentation slides are available at "5. Agenda".
Development, manufacturing, distribution and marketing of medical products have been increasingly globalized, and cooperation of regulatory activities amongst regulatory agencies and industries has become a necessity. Nowadays, East-Asian region has become significantly important in clinical development and manufacturing of drugs, and therefore, the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) are strengthening their activities to establish collaborative relationship with regulatory agencies in the East-Asian region.
This symposium is a joint conference hosted by the Taiwan-Japan Relations Association and the Japan-Taiwan Exchange Association. It is held as a part of cooperative activities under the MOU on medical products regulation signed between the Interchange Association and the Association of East Asia Relations on 5th November, 2013.
In this 5th symposium held in Taipei, most recent information on regulations of drugs and medical devices based on regulatory science and on national health insurance system will be shared. Also, safety management and quality control of medical products will be discussed.
Taiwan-Japan Relations Association
Japan-Taiwan Exchange Association
Support:
Taiwan Food and Drug Administration (TFDA)
Center for Drug Evaluation (CDE)
Pharmaceuticals and Medical Devices Agency (PMDA)
【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 (JSMI)
Asia-Pacific Self-Medication Industry (APSMI)
【Medical Devices Associations】
Japan Federation of Medical Devices Associations (JFMDA)
Taiwan Medical and Biotech Industry Association
Taiwan Federation of Medical Device Commercial Associations
Friday, December 1st, 2017
Chang Yung-Fa International Convention Center
(No.11, Zhongshan S. Rd., Taipei City)
URL:https://icc.cyff.org.tw/servlet/PUF1_ControllerServlet.do?lang=en&menu=PUF1&func=INDEX&action=VIEW_INDEX
Registration is free of charge. Please register from the website below:
https://www.praise-net.jp/pn/m/e.asp?id=MTA2MTE
Registration deadline: October 31th
Simultaneous translation will be provided for Japanese and Chinese.
Agenda
【Joint session 】
9:00-9:40 | Opening remarks (40 min) *5min each
|
9:40-11:00 | Keynote speeches (80 min)
Dr. Shou-Mei Wu, Director-General, TFDA, |
11:00-11:20 | Break/Memorial Photo Taking |
11:20-12:15 | Impact of MRCT after ICH E17 fully implement (55min) Moderator: Ms. Chyn-Liang Huang, Section Chief, Division of Medicinal Products, TFDA / Mr. Yoshihiko Sano, Office of International Programs, Deputy Director, MHLW
|
12:15-13:00 | Lunch Break |
13:00-13:40 | MC: Jessica H. Chou, Section Chief, Section of Project Management, CDE Generic drug (40 min) Moderator: Ms. Chyn-Liang Huang, Section Chief, Division of Medicinal Products, TFDA / Mr. Naoyuki Yasuda, Office Director, Office of International Programs, PMDA Q&A (15min) |
13:40-14:30 | Moderator: Ms. Chyn-Liang Huang, Section Chief, Division of Medicinal Products, TFDA / Mr. Yoshihiko Sano, Deputy Director, MHLW
|
14:30-14:50 | Break |
14:50-16:00 |
|
16:00-16:20 | Break |
Health Insurance | |
16:20-17:20 | Drug price adjustment under health insurance system (60min) Q&A (20min) |
17:20-17:30 | Closing Remarks (pharmaceuticals)
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11:20-12:15 | WG report & future image (55min) Moderator: Ms. Yumiko Aoyagi, Deputy Director, Medical Device Evaluation Division, MHLW
-Dr. Madoka Murakami, Unit Chief, Office of International Programs, PMDA
- Szu-Yu Lee, Specialist, TFDA (15min)
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12:15-13:00 | Lunch Break |
13:00-14:50 | Moderator: Ms. Cheng-Ning Wu, Section Chief, Division of Medical Devices & Cosmetics, TFDA
|
14:50-15:00 | Closing Remarks (medical devices)
|