5th Joint Conference of Taiwan and Japan on Medical Products Regulation

18^th October, 2017
Updated 7^th Decemeber, 2017
Updated 22^th Decemeber, 2017
Updated 26^th 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".

Date
Venue
Registration
Translation
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 5^th November, 2013.
　　In this 5^th 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 1^st, 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 31^th

Translation

Simultaneous translation will be provided for Japanese and Chinese.

Agenda

Agenda

【Joint session 】

9:00-9:40

Opening remarks (40 min) *5min each

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

9:40-11:00

Keynote speeches (80 min)

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

11:00-11:20

Break/Memorial Photo Taking

【Parallel session (Pharmaceutical)】

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 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) Q&A (15min)
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 Introduction of review points of generic drugs and BE guideline in Japan, Mr. Yoshihiko Sano, Deputy Director, Office of International Regulatory Affairs, MHLW (15min) Strength of Taiwan generic industry, Dr. Calvin Chen, President and CEO, TWi Biotechnology (10min) 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 Advanced approaches to assure pharmaceutical product quality - Lifecycle management (50min) Dr. Mei-Fang Chen, Senior Reviewer, Division of Medicinal Products, TFDA (25min) Mr. Kazuhiro Okochi, Chairman of ICH Quality Group, JPMA and Hiroshi Fujie, GMP Expert Committee, JPMA (25min)
14:30-14:50	Break
14:50-16:00	Cutting-edge technologies and strategies - Using real world data (50min) Dr. Kin-Wei Chan, Director, Clinical Trial Center, NTUH (25min) Ms. Kaori Yamada, Pharmacoepidemiologist, Office of Medical Informatics and Epidemiology, PMDA (25min) Q&A (20min)
16:00-16:20	Break
Health Insurance
16:20-17:20	Drug price adjustment under health insurance system (60min) Mr. Jau-Jic Huang, Senior Executive Officer, Medical Review and pharmaceutical Benefits Division, National Health Insurance Administration (20mim) Dr. Masanobu Yamate, Deputy Director, Economic Affairs Division, Health Policy Bureau, MHLW (20min) Q&A (20min)
17:20-17:30	Closing Remarks (pharmaceuticals) Dr. Shiow-Ing Wu, Deputy Director-General, TFDA Mr. Yoshihiko Sano, Deputy Director, Office of International Regulatory Affairs, MHLW

【Parallel session (Medical Devices)】

11:20-12:15	WG report & future image (55min) 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)
12:15-13:00	Lunch Break
13:00-14:50	Moderator: Ms. Cheng-Ning Wu, Section Chief, Division of Medical Devices & Cosmetics, TFDA 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) Mr. Wen-Wei Tsai, Technical Specialist, Division of Medical Devices & Cosmetics, TFDA (20min) Dr. Mari Shirotani, Division Director, Office of International Programs, PMDA (20min) Q&A (15min)
14:50-15:00	Closing Remarks (medical devices) Ms. Pei-Weng Tu, Director, Division of Medical Devices & Cosmetics, TFDA Dr. Mari Shirotani, Division Director, Office of International Programs, PMDA