訊息公告

提供本中心之相關活動與訊息或政府重要法規之發佈,各項資訊隨時更新。

活動訊息

3rd Joint Conference of Taiwan and Japan On Medical Products Regulation

刊登日期:2015-11-03  |  點閱次數 : 5553 次 
主辦單位: Taiwan Food and Drug Administration, TFDA、Center for Drug Evaluation, CDE
指導單位: East Asia Relations Commission、Interchange Association, Japan
活動地點: Chang Yung-Fa Foundation International Conference Center
活動日期: 26th November 2015

     Nowadays, Asian countries have become significant in clinical development and manufacturing of drugs globally, and therefore, the collaborative relationship among the Asian regulatory agencies are becomes highly important. On 5th November 2013, the Association of East Asian Relations, Taiwan, and the Interchange Association, Japan, had signed a MOU with the goal to enhance mutual understandings, and to construct a cooperative system across the region for further development in medical products. Then followed two joint conferences, organized by Taiwan FDA and Japan MHLW/PMDA, were held in 2013 and 2014 subsequently and focused on the discussion on pharmaceuticals and medical devices from the perspectives of regulation and health insurance system.

     The third Joint Conference of Taiwan and Japan on Medical Products Regulation will take place in Taipei at the Chang Yung-Fa Foundation International Conference Center on 26th November 2015. The main theme of this conference will be on the regulatory sciences collaboration and management experience sharing on medical products, and is aiming to discuss the new products development and collaboration on OTC, generic drugs, medical devices, and NHI system between Japan and Taiwan in depth.

本研討會以中文及日文進行,會場備有中日語之同步口譯。

會議議程
08:30-08:50 Registration (Rm. 1101)
08:50-09:00 Memorial Photo Taking
09:00-09:30                                                              Opening Remarks
- Mr. Jason Chou, Deputy Secretary-general, Association of East Asian Relations,  Taiwan
- Mr. Takashi Hamada, Secretary General, Interchange Association, Japan Taipei office, Japan
- Ms. Yu-Mei Chiang, Director-General, Taiwan FDA
- Dr. Toshiyoshi Tominaga, Associate Executive Director for International Programs, PMDA
- Mr. Wei-Jen Chen, President, Taiwan Pharmaceutical Manufacturers Association (TPMA)
- Mr. Kenichi Matsumoto, Vice Chairman, JFDMA
- Mr. Kiyoshi Horie, Asia Subcommittee, JPMA
09:30-10:10 Keynote Speech
Current status of medical products regulation in Taiwan and Japan

Moderator: Prof. Ming-Kung Yeh, Counselor, Ministry of Health and Welfare, Taiwan
- Dr. Shiow-Ing Wu, Deputy Director-General, Taiwan FDA (20mins)
- Dr. Kazuhiro Shigetoh, Executive Director, PMDA (20mins)
10:10-10:30 Coffee Break
Cooperation Accomplishments and Future Prospect for Japan-Taiwan Medical Products
10:30-11:30 Experience sharing on new product development in both Japan and Taiwan
Moderator: Ms. Li-Ling Liu, Director, Division of Medicinal Products, Taiwan FDA
1. Mr. Kouichi Tsuji, Terumo Corporation (20mins)
2. Prof. Chia-Chi Lin, International Center of Excellence in Cancer Research, Taiwan University (20mins)

Panel discussion (20mins)
11:30-12:30 How to exchange meaningful GCP information
Moderator: Dr. Junko Sato, Office Director, Office of International Cooperation, PMDA
1.Mr. Yosuke Kobayashi, Office of Non-Clinical and Clinical Compliance, PMDA (20mins)
2.Dr. Paul-Lee Wu, Director, Division of Medical Devices, Center for Drug Evaluation (20mins)

Panel discussion (20mins)
12:10-13:30 Luncheon

 

Parallel Session
Pharmaceutical (Rm. 1101) Medical device (Rm. 1001) 
13:30-14:30                                                                                  Collaboration between Taiwan and Japan for developing self-medication utilizing OTC
Moderator:Mr. Fumihito Takanashi, Deputy Director, Pharmaceutical Safety and Environmental Health Bureau, MHLW
1. Collaboration between Taiwan and Japan for Developing Non-prescription medicine Mr. Arthur Su, Board Member, Taiwan Pharmaceutical Marketing & Management Association (TPMMA) (20mins)
2. Mr. Motohito Nishizawa, Senior Advisor, Japan Self-Medication Industry, JSMI (20mins)

Panel discussion (20mins)
13:30-14:20  Currently regulation amendments and future prospects
1. Dr. Yu-Wen, Ruby Huang, Section Chief, Division of Medical Devices and Cosmetics, Taiwan FDA (20mins)
2. Mr. Hideyuki Kondo, Deputy Director, Medical Device and Regenerative Medicine Product Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, MHLW (20mins)

Panel discussion (10mins)Coffee Break
14:30-15:40 Collaboration between Taiwan and Japan for faster approval for new drugs: "Current progress and next steps"
Moderator:Dr. Shih-Chih Tsai, Senior Technical Specialist, Taiwan FDA
1. Dr. Kanako Takatsuki, Office of International Cooperation, PMDA (15mins)
2. Regulation comparison of new drug review between Taiwan and Japan (15mins)
Mr. Po-Yu Wang, Section Chief, Taiwan FDA (10mins)
3.Mr. Isao Sasaki, Astellas/ JPMA
4.Ms. Carol Cheng, Chief Operating Officer, Taiwan Research- based Biopharmaceutical Manufacturers Association (TRPMA)

Panel discussion for next step (20mins)
14:20-15:10  Learning, assessments and proposal for the collaboration activities in the medical device field 
1. Mr. Makoto Yokote, JFMDA (15mins)
2. Mr. Karen Ho, Manager, Regulation & Document Management Department, United Orthopedic Corporation (15mins)

Panel discussion (20mins)
15:10-15:40  Coffee Break
15:40-16:10  Progress of WG activities 
1. Product Registration WG: Dr. Madoka Murakami, Office of International Program, PMDA (10mins)
2. QSD/QMS WG:
Ms. Yu-Hsuan Chen, Senior Technical Specialist, Division of Risk Management, Taiwan FDA (10mins)

Panel discussion (20mins)
15:40-16:10 Coffee Break 16:10-16:20 Coffee Break
16:10-17:20 Collaboration between Taiwan and Japan for faster access to new drugs under NHI system
Opening remarks for NHI session
1. Ms. Ru-Liang Shih, Director, Medical Review and Pharmaceutical Benefits Division, NHIA (5mins)
2. Mr. Mimei Takahashi, Deputy Director, Economic Affairs Division, Health Policy Bureau, MHLW (5mins)

Presentation "Pricing effectiveness to realize faster access for NHI reimbursement"
1. Mr. Mimei Takahashi, Deputy Director, Economic Affairs Division, Health Policy Bureau, MHLW (20min)
2. Mr. Shang-Ping Chen, Researcher, Medical Review and Pharmaceutical Benefits Division, NHIA (20mins)

Panel discussion inviting key member of PBRS(20mins)

Panel discussion (20mins)
16:20-17:20

Closed meeting
17:20-17:40 Closing Remarks (1101 Room)
- Dr. Shiow-Ing Wu, Deputy Director-General, Taiwan FDA (10mins) 
- Dr. Kazuhiro Shigetoh, Executive Director, PMDA (10mins) 
17:40 Adjourn

 

報名資訊
注意事項 1.本研討會以中文及日文進行,會場備有免費之中日語同步口譯。
2.口譯設備僅限於報名時同步預定,並於活動當日憑「個人證件」借用耳機。
聯絡窗口 姓名:王啟光 或 朱文碧
電話:02-8170-6000 分機 111 或 617
信箱:ckwang519@cde.org.twwpchu342@cde.org.tw

 


上一筆 醫療器材GCP查核研討暨法規修正說明會