Conference & Workshop
【Update Date:2013-01-11】unit:醫療器材及化粧品組
2012 APEC-AHC-AHWP Joint Workshop on Medical Device Combination Products
Sunday, November 4, 2012
Venue: Room 101, 1F, Taipei International Convention Center (TICC)
Time
Session
Speaker/Panelist/Moderator
08:30 – 09:00
Opening Remark:Objective and expected outcome of the workshop
Opening Remark by AHC Director (video)
Photo Session
Ms. Li-Ling Liu,
AHWP Vice Chair,
Director, Division of Medical Device and Cosmetics, TFDA, DOH, Chinese Taipei
Dr. Kwang-Ho Lee
Director, APEC Harmonization Center/KFDA, Korea
09:00 – 09:30
Keynote: Updates on APEC
Mr. Mike Ward,
Chair of APEC RHSC/ Health Canada, Canada
09:30 – 11:10
Current Regulatory Perspectives and Challenges of APEC Economies on Regulating Medical Device Combination Products
Speakers:
Moderator:
Mrs. Elizabeth Baker, MHRA, UK
Ms. Janet Trunzo,
AdvaMed, USA
? USA
Mr. John (Barr) Weiner,
FDA, USA
? Japan
Dr. Yoichi Onodera,
PMDA, Japan
? Korea
Mr. Young-Min Kim,
KFDA, Korea
? China
Mr. Lian-Chun Yang,
SFDA, China
? Chinese Taipei : Survey Results of all APEC Economies
Dr. Hsien-Yi Lin,
TFDA, Chinese Taipei
11:10 – 11:40
Tea Break
11:40 – 12:40
The European Approach
Dr. Gert Bos,
BSI, UK
12:40 – 13:40
Lunch
13:40 – 14:30
Panel Discussion: Current Regulatory Perspectives and Challenges of APEC Economies on Regulating Medical Device Combination Products
All speakers and moderators from previous session
14:30 – 15:00
15:00 – 16:00
Case Studies of Combination Products Regulated as Medical Devices
? Drug-eluting stent
Ms. Geraldine Finn,
Medtronic, USA
Moderator:
Mr. Michael Gropp, Medtronic, USA
? Wound dressings with antibacterial properties
Mr. Scott Sardeson,
3M, USA
? Antibacterial orthopedic and neurological devices
Ms. Karen Sylvia,
Johnson & Johnson, USA
Panel Discussion and Q&A
16:00 – 17:30
Future direction: Potential Path Toward Convergence
? Definition
? Clinical Investigation (IDE)
? Premarket Review (PMA)
? GMP
? Post Market Surveillance
? International Cooperation
? Industry Perspective
Dr. Sethuraman Rama
HSA, Singapore
Mr. John (Barr) Weiner ,
Ms. Lindsay Tao,
Johnson & Johnson, China
Mr. John (Barr) Weiner , FDA, USA
17:30 – 17:50
Summary and Outcome of Workshop
Johnson & Johnson , China
17:50 – 18:00
Closing Remark
18:00
End of APEC-AHC-AHWP Joint Workshop on Medical Device Combination Products