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 ".
Purpose
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.
Host
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
Date
Friday, December 1st, 2017
Venue
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
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
Translation
Simultaneous translation will be provided for Japanese and Chinese.
Agenda
Agenda
【Joint session 】
- Mr. Ching-Hung Lin, Deputy Secretary General, Taiwan-Japan Relations Association
- Mr. Mitsuhiro Yokota, Deputy Representative, Taipei Office of the Japan-Taiwan Exchange Association
- Dr. Shou-Mei Wu, Director-General, TFDA
- Mr. Seiichi Inoue, Executive Director, PMDA
- Mr. Wei-Jen Chen, President, TPMA
- Mr. Akihiko Matsubara, Managing Director, JPMA
- Mr. Francis Hong, President, TMBIA
- Mr. Kenichi Matsumoto, Vice Chairman, JFMDA
- Regulatory updates in Taiwan, Dr. Shou-Mei Wu, Director-General, TFDA (30min)
- Regulatory updates in Japan, Mr. Seiichi Inoue, Executive Director, PMDA (30min)
- Q&A (20min)
Dr. Shou-Mei Wu, Director-General, TFDA,
Ms. Chao-Yi Wang, Director, Division of Medicinal Products, TFDA,
Ms. Pei-Weng Tu, Director, Division of Medical Devices & Cosmetics, TFDA
Mr. Seiichi Inoue, Executive Director, PMDA,
Mr. Naoyuki Yasuda, Office Director, Office of International Programs, PMDA
【Parallel session (Pharmaceutical)】
Moderator: Ms. Chyn-Liang Huang, Section Chief, Division of Medicinal Products, TFDA / Mr. Yoshihiko Sano, Office of International Programs, Deputy Director, MHLW
- Regulatory perspective, Mr. Shuji Kamada, Reviewer, Office of New Drug V, PMDA (15min)
- Academic perspective, Dr. James Chih-Hsin Yang, Director, Department of Oncology, NTUH (15min)
- Industry perspective, Mr. Chikara Kikuchi, Sr. Director, Regulatory Affairs, Development Japan, Pfizer Japan Inc. (10min)
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)
- Advanced approaches to assure pharmaceutical product quality - Lifecycle management (50min)
- Cutting-edge technologies and strategies - Using real world data (50min)
- Dr. Shiow-Ing Wu, Deputy Director-General, TFDA
- Mr. Yoshihiko Sano, Deputy Director, Office of International Regulatory Affairs, MHLW
【Parallel session (Medical Devices)】
Moderator: Ms. Yumiko Aoyagi, Deputy Director, Medical Device Evaluation Division, MHLW
- Product registration WG
-Dr. Madoka Murakami, Unit Chief, Office of International Programs, PMDA
(15min)
- QMS WG
- Szu-Yu Lee, Specialist, TFDA (15min)
- Hideki Asai, JFMDA (10min)
- Q&A (15min)
- Postmarket evaluation techniques: Evaluation of postmarket clinical benefits and risks of medium-high risk medical devices (50min)
- Dr. Kin-Wei Chan, Clinical Trial Center, NTUH (20 min)
- Ms. Yumiko Aoyagi, Deputy Director, Medical Device Evaluation Division, MHLW (20min)
- Q&A (15min)
- International trend on medical device regulatory convergence (50min)
- Ms. Pei-Weng Tu, Director, Division of Medical Devices & Cosmetics, TFDA
- Dr. Mari Shirotani, Division Director, Office of International Programs, PMDA