Conference & Workshop
【Update Date:2013-01-11】unit:醫療器材及化粧品組
Time
Session
Speaker
Moderator/ Facilitator
08:00 – 08:10
Opening Speech
Mrs. Joanna Koh,
Chair, AHWP Technical Committee/ HSA, Singapore
08:10 – 08:20
Welcome Address
Dr. Shiow?Ing Wu
Deputy Director?General, TFDA, DOH, Chinese Taipei
08:20 – 08:30
Souvenirs to Speakers & Photo Taking
08:30 – 09:30
Affordable and Accessible IVD
Prof. Rosanna Peeling, LSHTM, UK
Dr. Chun-Nan Lee,Professor, Department of Clinical Laboratory Sciences and Medical Biotechnology, College of Medicine, NTU, Chinese Taipei
09:30 –10:00
Tea break
10:00 – 12:00
Clinical rationale (basis) of Medical Devices and Medical Technology advances in Medical Device
Panel Discussion and Q&A
Mr. Rainer Voelksen
Edwards Lifesciences, France
Dr. Rong-Sen Yang, Dept. Orthopedics Surgery, NTUH, Chinese Taipei
Dr. Peter Staehr
Abbott Vascular, USA
12:00 – 13:00
Lunch
Parallel Session 1 (Mega Room 1,
Level 8, W Taipei)
Parallel Session 2 (Mega Rooms 2 + 3,
13:00 – 14:30
Quality Management System (QMS)
Mr. Grant Ramaley, IAF, Australia
(1,2,3)
Mr. Albert Li, ITRI, Chinese Taipei
Dr. Han-Son Dawn, Taiwan Medical and Biotech
Industry Association, Chinese Taipei
Introduction and International Comparative Overview
Ms. Nicole Denjoy, Vice-Chair, DITTA , EU
Dr. Yio-Wha Shau, General Director, BDL, ITRI, Chinese Taipei
European Union: How Medical Software are currently regulated?
Mr. Laurent Selles, DG SANCO, EC
USA & Canada: Regulation and Guidelines on Medical Software
Dr. John Abbott, MITA, Chair IEC TC87, USA
Overview of Global Issues and Activities Related to Counterfeit /Falsified Medicines
Mr. Jeffrey Gren, Department of Commerce, USA
Latest Developments on Medical Software inJapan
Mr. Susumu Takahashi, JIRA, Japan
All Speakers
14:30-15:00
15:00 – 16:30
Enhancement of Post-market Surveillance
Experiences in EU
Mr. Laurent Selles, DG SANCO, European Commission, EU
Dr. Jau-Min Wong,
NationalTaiwan University, Chinese Taipei
Status on Standards Development for Medical Software
Dr. Peter Linders, Chair of CENELEC TC 62 Chair and Co-leader of IEC 82304-1, EU
Ms. Nicole Denjoy, Vice-Chair, DITTA, EU
Elements of a successful registry in the post-market surveillance system
Medical Software and IEC 62304 in Europe: Frequently Asked Questions on Interpretation and Application
Mr. Michael Bothe, VDE Testing & Certification Institute, EU
- Experiences in Chinese Taipei
Ms. Tina Wu, TFDA, DOH, Chinese Taipei
Practical Cases
Mr. Maurizio Andreano, COCIR, EU
- Experiences in Japan
Dr. AtsushiTamura,
PMDA, Japan
Panel discussion and Q&A
All speakers
Closing Remark
Mrs. Joanna Koh, Chair, AHWP TC/HSA, Singapore
16:30
End of AHWP TC Training Workshop