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2012 AHWP Technical Committee Meeting (Nov. 2nd)

Agenda 【Date:2013-01-11】 unit:醫療器材及化粧品組

AHWP TC Pre-Meeting

Friday AM, November 2, 2012

Venue: Great Room, Level 8, W Taipei

Time

Session

Speaker/Moderator

09:00 – 11:00

AHWP TC Working Group PRE-MEETING

(Closed Meeting)

WG Chair / Co-chair

11:00 – 12:00

AHWP TC Leaders Meeting with AHWP Chair

(Closed Meeting)

TC Leaders & AHWP Chair

12:00 – 13:00

Lunch

 

AHWP TC Meeting

Friday PM, November 2, 2012

Venue: Mega Room, Level 8, W Taipei 

Time

Session

Speaker/Moderator

13:00 – 13:10

Welcome Address

Dr. ShiowIng Wu

Deputy Director-General, TFDA, DOH, Chinese Taipei 

13:10 – 13:20

Opening Speech by AHWP Chair

Dr. Saleh S. Al-Tayyar, Chair, AHWP

Director-General, Medical Devices Sector,

SFDA, Kingdom of Saudi Arabia

13:20 – 13:30

·           Roll-call

 

·           Adoption of Agenda

AHWP Secretariat

 

Mrs. Joanna Koh, Chair, AHWP TC

Director, Medical Device Branch, Health Sciences Authority, Singapore

 

Mr. Ali M. Al-Dalaan, Co-chair, AHWP TC

Executive Director, Medical Device Sector, SFDA, Kingdom of Saudi Arabia

Ms. Chadaporn Tanakasemsub, Co-chair, AHWP TC

Vice President,  
Asia Pacific Quality Assurance/Regulatory Affairs
Zimmer, Asia Pacific, Singapore

13:3013:45

Updates on AHWP TC Leaders Meeting in Chinese Taipei with AHWP Chair (Nov 2, 2012)

Mrs. Joanna Koh, Chair, AHWP TC

Director, Medical Device Branch, Health Sciences Authority, Singapore

13:45 – 14:00

 

Report and Overview of TC Meeting in Manila (June 2012)

Mr. Ali M. Al-Dalaan, SFDA, Kingdom of Saudi Arabia  

Ms. Chadaporn Tanakasemsub, Zimmer, Asia Pacific, Singapore

14:0014:15

Updates by WG1

(Pre-Market Submission)

Ms. Huifen Bai, HSA, Singapore

Mr. Alfred Kwek, GE Healthcare, Singapore

14:1514:30

Updates by WG1a

(In-vitro Diagnostic Device)

Ms. Li-Ling Liu, TFDA, Chinese Taipei 

Mr. Jeffrey Chern, ITRI, Chinese Taipei

14:30 – 14:45

Updates by WG2

(Post-Market Surveillance and Vigilance)

Mr. Yorkie Chow, DOH, Hong Kong SAR

Dr. Kulwant Saini, Johnson & Johnson, India

14:45 – 15:00

Tea Break

15:00 – 15:15

Updates by WG3

(Quality Management System)

Mr. Ali M. Al-Dalaan, SFDA, Kingdom of Saudi Arabia

Mr. Ee Bin Liew, Philips Healthcare, Singapore

15:15 – 15:30

Updates by WG4

(Quality System Audit)

 

Mr. Abdullah Al-Rasheed, SFDA, Kingdom of Saudi Arabia

Ms. Eun Hee Cho, Abbott Vascular, Korea

15:30 – 15:45

Updates by WG5

(Clinical Evidence Requirements)

Ms. Sumati Randeo, Abbott Laboratories, India

15:45 – 16:00

Updates by WG6

(Capacity Building and Regulatory Training)

Dr. Rama Sethuraman, HSA, Singapore

Mr. Jack Wong, Johnson & Johnson, Singapore

16:00 – 16:15

Updates by STG (N)

(Medical Device Nomenclature)

Mr. Lian-Chun Yang, SFDA, China

Ms. Carol Yan, Johnson & Johnson, China

16:15 – 16:30

- Update from Secretariat (Resolutions to be resolved in the Main Meeting)" 

- AHWP TC Meeting Closing Remark

Mr. Bryan So, HKPC, Hong Kong SAR

 

 

Mrs. Joanna Koh, HSA, Singapore

End of AHWP TC Meeting