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2014 International Forum on Medical Device Combination Products

Release Date：2014-10-07  |  Visitors : 7912
Organizer： Center for Drug Evaluation, Taiwan
Supervision： Food and Drug Administration, Ministry of Health and Welfare, Taiwan
Venue： National Taiwan University Hospital (NTUH) International Convention Center, Room 401
Date： October 23, 2014 (Thursday) / 9:00~17:00
Program

 

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

 

Registration

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