Conference & Workshop
【Update Date:2013-01-11】unit:醫療器材及化粧品組
The 17th AHWP Annual Meeting
Monday, November 5, 2012
Venue: Room 101, 1F, Taipei International Convention Center (TICC)
Time
Session
Speaker/Moderator
08:00 – 08:10
Welcome Speech
Dr. Jaw-Jou Kang, Director-General, TFDA, Department of Health, Chinese Taipei
08:10 – 08:15
Congratulation Speech
Mr. Abdulrahman Al Ghurairi
Director, International Cooperation Department, SFDA, Kingdom of Saudi Arabia
08:15 – 08:25
Opening Speech
Dr. Saleh S. Al-Tayyar,
Chair, AHWP
Director General, Medical Devices Sector, SFDA, Kingdom of Saudi Arabia
08:25 – 08:35
Speech by Honorable Guest
Dr. San-Cheng (Simon) Chang, Minister without Portfolio, Executive Yuan, Chinese Taipei
08:35 – 08:55
Souvenirs to Host, Honorable Guest and Sponsors
Group Photo
08:55 – 09:25
Keynote Speech
Medical Device Developments and Regulation Updates in Chinese Taipei
Dr. Huihua Chiang
Executive Secretary, Board of Science and Technology, Executive Yuan, Chinese Taipei
09:25 – 09:45
Tea Break
09:45 – 10:15
GHTF Status Report
Mr. Kentaro Azuma
Deputy Director
Office of Medical Device Evaluation, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, Japan
10:15 – 10:45
IMDRF Status Report
Dr. Atsushi Tamura
International Coordination Officer for Medical Devices, Pharmaceuticals and Medical Devices Agency, Japan
10:45 – 12:00
AHWP Status Report and Strategic Framework Including announcement of the AHWP Conference
- Adoption of Agenda
- Roll Call (Only Official Members)
- Confirmation on Minutes of 16th AHWP Meeting held in Indonesia, 8-12 Nov 2011
- Discussion on the proposed ”AHWP Strategic Framework Towards 2020 - The Foreseeable Harmonization Horizon”
- Introduction to the 1st AHWP-RAPS Joint Conference
Director General, Medical Devices Sector,
SFDA, Kingdom of Saudi Arabia
Ms. Lindsay Tao
Vice Chair, AHWP
Corporate Director, Global health Policy, Johnson & Johnson, China
Ms. Quan Tran
Advisor to Chair, AHWP
Vice President, Quality Assurance & Regulatory Affairs, Asia Pacific, GE Healthcare, Singapore
12:00 – 13:00
Lunch
13:00 – 14:20
Country Update
i) China
ii) Thailand
iii) Indonesia
iv) Brazil
v) Chile
Country representatives
14:20 – 14:40
14:40 – 15:20
Report by AHWP TC
Mrs. Joanna Koh
Chair, AHWP TC
Director, Medical Device Branch, Health Sciences Authority, Singapore
15:20 – 15:50
Report by Secretariat
- Report by AHWP Secretariat from 2011 to 2012
- Report on Financial Statement for 2011/2012
- Proposal for Budget 2012/2013
Mr. Ali M. Al-Dalaan
Secretary General, AHWP
Executive Director, Medical Device Sector, SFDA, Kingdom of Saudi Arabia
Mr. Bryan So
Executive Deputy Secretary General, AHWP
Senior Consultant, Hong Kong Productivity Council, Hong Kong SAR
15:50 – 16:10
16:10 – 16:40
- Resolution 1: Adoption of the Proposed “Amendment 2 to the AHWP & AHWPTC Terms of Reference” (by Mr. Bryan SO)
- Resolution 2: Adoption of the Proposed “Amendment 1 to the AHWP House Rules” (by Mr. Bryan SO)
- Endorsement on the Proposed “Medical Device Adverse Event (AE) Report Form” (by Mr. Yorkie CHOW)
- Endorsement on the Proposed "Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions” (by Mr. Yorkie Chow)
-Endorsement on the Proposed “Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers“ (by Mr. Abdullah A. Al-Rasheed)
16:40 – 16:50
Confirmation of Host of the 18th AHWP Meeting
16:50 – 17:00
Closing Remarks
Ms. Li-Ling Liu,
Director, Division of Medical Device and Cosmetics, TFDA, Department of Health, Chinese Taipei
17:00 – 18:00
1st AGM of AHWP ASL (Open to Industry and Regulatory Representatives of AHWP Member Economies)
- Introduction of ASL
- Admission of New ASL Members
- Election of Lindsay TAO, Li-Ling Liu, Quan Tran, and Chadaporn Tanakasemsub as the Directors of the Board
18:00
End of the 17th AHWP Annual Meeting
18:30 – 21:00
Gala Dinner (3F Banquet Hall, TICC)