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

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 Head External Affairs Roche Diagnostics India & Neighbouring Markets India	Industry
Secretary:	Ms. Mie Ohama Senior Clinical Quality Manager Medtronic Australasia Pty Ltd Australia	Industry
Advisor:	Ms Shelley Tang Principal Stellar consulting Australia	Industry
Advisor:	Dr. Martin A. Devitt 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:	Ms. Thangavelu SASIKALA MD Bureau Ministry of Health Malaysia	Regulatory Authority
Member:	Dr. KRISHNASAMY Mariammah Senior Assistant Director Medical Device Control Division 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:	Mr. Peter Kyong-Ho LEE Manager International Regulatory Affairs Institut Straumann AG Basel	Industry
Member:	Ms. Linda LIN Boston Scientific	Industry
Member:	Dr. Xianqiang MI Associate Professor University of Shanghai for Science and Technology Shanghai People's Republic of China	Industry
Member:	Honglei SUN Clinical Affairs Manager Medtronic People's Republic of China	Industry
Member:	Loi VU THI Johnson & Johnson Vietnam	Industry
Member:	Ms. Yuhong, Amber WANG RA Director Medtronic People's Republic of China	Industry
Member:	Ms. Woei Jiuang WONG Director Medical Device Branch Pre-Marketing Division Health Products Regulation Group Health Sciences Authority	Industry
Member:	Ms. Jirui, Carol YAN RA Director Johnson & Johnson Medical People's Republic of China	Industry
Member:	Mr. SINGH Kanwarjit VP, Medical & Clinical Affairs and Development Johnson & Johnson Medical Asia Pacific Singapore	Industry
Member:	Ms. Shiwani Zalpuri Associate Regulatory Affairs India & South Asia Abbott Healthcare Pvt. Ltd. India	Industry
Member:	Ms. Ahong Freda JIANG Director, Regulatory Affairs BD People's Republic of China	Industry
Member:	Dr. WILKINSON Anthony General Manager Cook Asia Limited Hong Kong SAR, China	Industry
Member:	Dr. WANG Dong Yan, Tony Clinical Affairs Manager Cook Medical (China) People's Republic of China	Industry
Member:	Dr. Qian Liang Head of Medical Devices, APAC BSI Hong Kong	Industry
Member:	Mr. Gaurav Verma Principal Consultant Asia Actual India (OPC) Private Limited India	Industry
Member:	Ms. Asma Zuberi Senior Regulatory Affairs Specialist MENA Smith and Nephew Pakistan	Industry
Member:	Ms. Ye GUO Regulatory Affairs Johnson & Johnson Medical (Shanghai) Ltd People's Republic of China	Industry
Member:	Ms. Yan FENG Sr Manager Government & Regulatory Affairs Philips Healthcare People's Republic of China	Industry
Member:	Mr. Justin YOO RA,QA, and Reimbursement & Health Economics St.Jude Medical Republic of Korea	Industry
Member:	Ms. Mie Ohama Sr. Clinical Quality Manager APAC Medtronics Coporate Clinical Quality & Compliance Australia	Industry
Member:	Ms. Sang Hag LEE R&D Center Director MEKICS Co., Ltd Republic of Korea	Industry
Member:	Ms. Jung Hyun SUNG Manager Corentec Co., Ltd	Industry
Member:	Dr. Ganesh Babu Head Clinical & Regulatory Affairs Carl Zeiss India (Bangalore) Pvt Ltd	Industry

Work Plan and Target:

AHWP_TC_WG05_Work Plan 2012-2014