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2012 AHWP Annual Meeting (Nov.5th)

Agenda 【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

08:3508:55

Souvenirs to Host, Honorable Guest and Sponsors

Dr. Saleh S. Al-Tayyar,

Chair, AHWP

Director General, Medical Devices Sector, SFDA, Kingdom of Saudi Arabia

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

Dr. Saleh S. Al-Tayyar,

Chair, AHWP

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 

Tea Break

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

Tea Break

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)

Dr. Saleh S. Al-Tayyar,

Chair, AHWP

Director General, Medical Devices Sector,

SFDA, Kingdom of Saudi Arabia

16:40 – 16:50

Confirmation of Host of the 18th AHWP Meeting

Dr. Saleh S. Al-Tayyar,

Chair, AHWP

Director General, Medical Devices Sector, SFDA, Kingdom of Saudi Arabia

16:50 – 17:00

Closing Remarks

Ms. Li-Ling Liu,

Vice Chair, AHWP

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)

- Adoption of Agenda

- 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

Mr. Ali M. Al-Dalaan

Secretary General, AHWP

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

18:00

End of the 17th AHWP Annual Meeting

18:30 – 21:00

Gala Dinner (3F Banquet Hall, TICC)