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

2014 International Forum on Medical Device Combination Products

刊登日期:2014-10-07  |  點閱次數 : 7848 次 
主辦單位: Center for Drug Evaluation, Taiwan
指導單位: Food and Drug Administration, Ministry of Health and Welfare, Taiwan
活動地點: National Taiwan University Hospital (NTUH) International Convention Center, Room 401
活動日期: October 23, 2014 (Thursday) / 9:00~17:00
會議議程

 

Time Topic Speaker
8:30-9:00 Registration
Session A.
Moderator: Dr. Ming-Che Wang
                     Director, Division of Medical Devices, Center for Drug Evaluation, Taiwan
9:00-10:00 Combination Products in Europe – Current Issues and Topics Mrs. Elizabeth Baker
Group Manager, Licensing Group 1 and Drug/Device Enquiries, Medicines and Healthcare Products Regulatory Agency
10:00-10:20 Coffee Break
10:20-11:20 Combination Products in US – Recent Developments and Lessons Learned Dr. John Barlow Weiner
Associate Director, Office of Combination Products, US Food and Drug Administration 
11:20-12:00 Update of Combination Product Project in APEC RHSC and Potential Future Work to Promote Regulatory Convergence Dr. Hsien-Yi Lin 
Senior Reviewer, Division of Medical Devices and Cosmetics, Food and Drug Administration, Ministry of Health and Welfare, Taiwan 
12:00-13:30 Lunch
Session B.
Moderator: Dr. Rong-Sen Yang
                     Professor and Chairman, Department of Orthopaedics College of Medicine, National Taiwan University
13:30-14:30 Combination Product: A case study Mrs. Maria Esbella Ruiz
International Regulatory Affairs Specialist, 3M Health Care Business Group, USA
14:30-15:30 Update of Combination Product Project in AHWP and Potential Cooperation Between APEC and AHWP Mr. Jack Wong
Director, Regulatory Affairs, Asia Pacific at Terumo BCT
15:30-15:50 Coffee Break
15:50-16:50 Panel Discussion: All Speakers
Moderator: Dr. Rong-Sen Yang
Professor and Chairman, Department of Orthopaedics College of Medicine, National Taiwan University
16:50-17:00 Closing Remarks Food and Drug Administration, Ministry of Health and Welfare, Taiwan

 

報名資訊