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

Chair:	Mr. Fikriansyah Bin Irman Medical Device Reviewer Ministry of Health Indonesia	Regulatory Authority
Co-Chair:	Ms. Ong Yean Ting Head Quality and Regulatory Roche Diagnostics Malaysia Sdn Bhd	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. Stephanie Shedd International Affairs Policy Analyst Food and Drug Administration Center for Devices and Radiological Health USA	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
Member:	Ms. Wenny Budiyanti Sr. Regulatory Affair Director Regulatory Affairs Specialist PT. Mindray Medical Indonesia Indonesia	Industry
Member:	Ms. Jean Lei Regulatory Affairs Manager Shenzhen Mindray Biomedical Electronics Co., Ltd. People's Republic of China	Industry
Member:	Mr. Leonard Hovestadt EU Director Governmental Affairs Elekta Netherlands	Industry
Member:	Ms. Amber Wang VP, Regulatory Affairs and Quality Assurance, Genesis MedTech Group People's Republic of China	Industry
Member:	Ms. Yi Gu Associate Director, Regulatory Affairs, Johnson & Johnson Medical Shanghai People's Republic of China	Industry

Work Plan and Target:

GHWP_TC_WG05_Work Plan 2012-2014