4th Joint Conference of Taiwan and Japan on Medical Products Regulation

The 4th Joint Conference of Taiwan and Japan on Medical Products Regulation has concluded. Thank you for participating.

1. Date
2. Venue
3. Registration and Inquiries
4. Translation
5. Agenda

Purpose

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 5^th November 2013. In the 4^th 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.
 

Host

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
 

Date

December 7, 2016

Venue

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/#

Registration and Inquiries

Registration is free of charge. Please register from the website below:
Please note registraion will be closed when it reaches capacity. Registered participants will receive confirmation email from conference secretariat.
https://www.praise-net.jp/pn/m/e.asp?id=OTE4MA

Inquiries:
JPMA, International Affairs      Fujii / Kijima
TEL:03-3241-0340
FAX:03-3242-1767
Email:kijima@jpma.or.jp

JFMDA, International Affairs    Naito / Tanaka
TEL:03-5225-6234
FAX:03-3260-9092
Email:global@jfmda.gr.jp

Translation

Simultaneous translation will be provided for Japanese and Chinese.

Agenda

Agenda (PDF version)
 

Joint Session
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) Toshiyoshi Tominaga, Associate Executive Director for International Programs, PMDA (25min)  Ms. Chao-Yi Wang, Director, Division of Medicinal Products, TFDA (25min) Q and A (10min)
10:40-10:55	Coffee Break

 

Parallel Session (Pharmaceuticals)
10:55-11:55	Moderator: Ms. Chao-Yi Wang (TFDA) WGs Progress Report -New drugs Dr. Yi-Chu Lin, Section Chief, Division of Medicinal Products, TFDA (8min) -GCP Mr. Ryosuke Sakai, Inspector, Office of Non-clinical and Clinical Compliance, PMDA (8min) -OTC drugs Mr. Heng-Jung Lien, Section Chief, Division of Medicinal Products, TFDA (8min) -OTC drugs Mr. Fumihito Takanashi, Assistant Director, Office of International Regulatory Affairs, MHLW (8min) -Generic drugs Mr. Naoyuki Yasuda, Office Director, Office of International Programs, PMDA (8min) Panel Discussion (20min)
11:55-13:00	Luncheon
13:00-13:50	Moderator: Mr. Naoyuki Yasuda (PMDA) New Strategies and Technologies 3D printing Prof. Jeng-Ywan Jeng, National Taiwan University of Science and Technology (20min) Electronic tools used in safety measures Mr. Atsushi Noguchi, Coordinator, Office of Medical Informatics and Epidemiology, PMDA (20min) Panel Discussion (10min)
13: 50-15:05	Moderator: Dr. Churn-Shiouh Gau (CDE) Experience Sharing on maintaining safety and quality of pharmaceuticals Regulatory perspective API regulation and post-approval change: Current management in Taiwan Mr. Heng-Jung Lien, Section Chief, Division of Medicinal Products, TFDA (15min) Consideration point of post-approval change Mr. Go Yamamoto, Deputy Director, Pharmaceutical Evaluation Division, MHLW (15min) Description of the demanded document of API for the application of registration of generic medicine in Japan Mr. Ryosuke Kuribayashi, Chief Reviewer, Office of Generic Drugs, PMDA (15min) Industry perspective Post-approval change application Dr. Alice Hsu, Standard Chemical & Pharmaceutical Co, TW (10min) Post-approval change application Mr. Tomonori Nakagawa, Asia Project Leader, GMP Sub Committee, Quality & Technology Committee, JPMA (10min) Panel Discussion (10min)
15:05-15:20	Coffee Break
15:20-16:20	Moderator: Mr. Yoshihiko Sano (MHLW) Post-marketing Management Safety information (including vaccine) report and research in Japan Dr. Daisaku Sato, Division Director, Safety Division, MHLW(15min) Adverse Event Reporting Current Status and policy direction on "Adverse Event Reporting" Ms. Wen-Wen Chen, CEO, Taiwan Drug Relief Foundation (15min) Current Status and policy direction on "Adverse Event Reporting" Ms. Mariko Tsukuda, Reviewer, Office of Safety I, PMDA (15min) 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 Current update in NHI policy and future directions Mr. Hiroaki Mamiya, Section Chief, Economic Affairs Division, MHLW (20min) Current update in NHI policy and future directions Mr. Chang-Jr Chen, Specialist, Medical Review and Pharmaceutical Benefits Division , NHIA (20min) Panel discussion (20min)
Pharmaceuticals &Health Insurance
17:20-17:30	Closing Remarks - Ms. Chao-Yi Wang, Director, Division of Medicinal Products, TFDA - Dr. Toshiyoshi Tominaga, Associate Executive Director, PMDA
18:00-	Welcome Reception (Nihonbashi Life Science Bldg. 10F)

 

Parallel Session (Medical Devices)
11:15-11:45	Moderator: Ms. Yumiko Aoyagi (MHLW) Progress of Product Registration WG Dr. Ta-Jen Wu, Technical Specialist, Division of Medical Devices and Cosmetics, TFDA (15min) Panel Discussion (15min)
11:45-13:15	Luncheon
13:15-13:45	Moderator: Ms. Yumiko Aoyagi (MHLW) Progress of QSD/QMS WG Mr. Katsuya Sawadaishi, Inspector, Division of Medical Devices, Office of Manufacturing/ Quality and Compliance, PMDA (15min) Panel Discussion (15min)
13:45-15:30	Moderator: Mr. Ming-Shin Lee, Director, Division of Risk Management, (TFDA) Information sharing on recent topics Software validation Mr. Tzu-Wei Li, Industrial Technology Research Institute of Taiwan (20min) Mr. Keiichiro Ozawa, FUJIFILM Corporation (20min)  In Vitro Companion Diagnostic Devices Mr. Tzu-Wei Li, Industrial Technology Research Institute of Taiwan (20min) Ms. Yumiko Aoyagi, Deputy Director, Medical Device Evaluation Division, MHLW (20min) Panel Discussion (25min)
15:30-15:40	Closing Remarks - Ms. Yu-Roo Chu, Deputy Director, Division of Medical Devices and Cosmetics, TFDA - Dr. Yuka Suzuki, International Coordination Officer, Office of International Programs, PMDA
15:40-16:00	Coffee Break
16:00-17:30	Closed Meeting Product Registration WG closed meeting QSD/ QMS WG closed meeting
18:00-	Welcome Reception (Nihonbashi Life Science Bldg. 10F)