Work Group 5 (WG5) - Clinical Evidence for Performance and Safety

Submitted by admin on Fri, 06/02/2017 - 16:44
Chair:

Mr. Fikriansyah?Bin Imran
Health Administrator
Directorate of Medical Device and Household Health Products Evaluation
Directorate General of Pharmaceuticals and Medical Devices
Ministry of Health
Republic of Indonesia

Regulatory Authority

Co-Chair:

Ms.?Sumati Randeo
Director Government Affairs
Danaher Corporation
India

Industry

Secretary:

Ms. Mie Ohama
Compliance Manager, Audit Management GQC
Quality and Enterprise Learning
PPD
Australia

Industry
Advisor: Ms Shelley Tang
Principal
Stellar consulting
Australia
Industry
Advisor: Dr. A. Devitt?Martin
Managing Director
Lifecycle Medical
Australia
Industry
Member: Mr. Abdullah Salem AL-DOBAIB
Executive Director of Registration and Licensing Department
Medical Device Sector
Saudi Food & Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority
Member: Dr. Mariammah?KRISHNASAMY
Senior Assistant Director of Premarket Division
Medical Device Authority
Ministry of Health Malaysia
Malaysia
Regulatory Authority
Member: Mr. SIU Hiu Fai Stanley
Engineer
Electrical and Mechanical Services Department
Government of the Hong Kong
Special Administrative Region
Hong Kong SAR, China
Regulatory Authority
Member: Dr. Chi Won SONG
Deputy Director
Ministry of Food and Drug Safety
Republic of Korea
Regulatory Authority
Member: Mr. Se Kyung KIM
Assistant Director
Ministry of Food and drug Safety
Republic of Korea
Regulatory Authority
Member: Hsiau-Wen HUANG
Senior Researcher
Ministry of Health and Welfare
Chinese Taipei
Regulatory Authority
Member: Ms. Shiwani Zalpuri
Regulatory Affairs
GE Healthcare
India
Industry
Member: Dr. Qian Liang
Head of Medical Devices, APAC
BSI
Hong Kong
Industry
Member: Ms. Asma Zuberi
Senior Regulatory Affairs
Specialist?
Gulf & Pakistan
Baxter A.G Scientific Office
Industry
Member:

Mr. Justin YOO
Professor & Head
Dongguk University & A bio Medical Venture Firm?
Republic of Korea

Industry
Member: Ms. Sang Hag LEE
R&D Center Director
Mekics Co., Ltd
Republic of Korea
Industry
Member: Mr. Chi Keung Alexis KWAN
Quality Manager
VTech Communications Ltd.
Hong Kong
Industry
Member: Ms. Rena HAN
Sr. Regulatory Affair Director
Boston Scientific?
People's Republic of China
Industry

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Work Plan and Target:?

GHWP_TC_WG05_Work Plan 2012-2014

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