Conference & Workshop
【Update 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
TC Leaders & AHWP Chair
12:00 – 13:00
Lunch
AHWP TC Meeting
Friday PM, November 2, 2012
Venue: Mega Room, Level 8, W Taipei
13:00 – 13:10
Welcome Address
Dr. Shiow?Ing 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
13:30 – 13:45
Updates on AHWP TC Leaders Meeting in Chinese Taipei with AHWP Chair (Nov 2, 2012)
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
14:00 – 14:15
Updates by WG1
(Pre-Market Submission)
Ms. Huifen Bai, HSA, Singapore
Mr. Alfred Kwek, GE Healthcare, Singapore
14:15 – 14:30
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. 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