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2012 AHWP Technical Committee Training Workshop (Nov.3rd)

Agenda 【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. ShiowIng Wu

Deputy DirectorGeneral, TFDA, DOH, Chinese Taipei

08:20 – 08:30

Souvenirs to Speakers & Photo Taking

Dr. ShiowIng Wu

Deputy DirectorGeneral, TFDA, DOH, Chinese Taipei

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,

Level 8, W Taipei)

Time

Session

Speaker

Moderator/ Facilitator

Session

Speaker

Moderator/ Facilitator

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

Panel Discussion and Q&A

All Speakers

Panel Discussion and Q&A

All Speakers

14:30-15:00

Tea break

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

 

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