Chair: |
Dr. Seil Park Email: parkseil@korea.kr |
Regulatory Authority | |
Co-Chair: |
Ms. Mandy Myoung Shim Kim Email: mkim65@its.jnj.com |
Industry | |
Advisor: |
Dr. Arthur Brandwood |
Industry | |
Advisor: | Mr. Edward Woo RA Lead Asia Pacific & India Sub-Continent Philips Hong Kong SAR |
Industry | |
WG 1 Secretary: |
Ms. Yesong PARK |
Industry | |
Member: | Mr. Alamri Mesha'l Executive Director Premarket & Scientific Evaluation Management Medical Devices Sector Saudi Food & Drug Authority Kingdom of Saudi Arabia |
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Member: | Dr. Felista Chepwogen Head of medical devices and diagnostics department National Medicines Regulation Officer Kenya |
Regulatory Authority | |
Member: | Ms. Faiza Said AL Zadjali Eng Director of Medical Device Control DGPA & DC Ministry of Health Sultanate of Oman Sultanate of Oman |
Regulatory Authority | |
Member: | Ms. Hanadi Alousaimi Senior Scientific Evaluation Specialist Saudi Food and Drug Authority Kingdom of Saudi Arabia |
Regulatory Authority | |
Member: | Mr. Shiqing Zhang Deputy Director of Quality Management Department Center for Medical Device Evaluation People's Republic of China |
Regulatory Authority | |
Member: | Ms. Liyun Gao Senior Regulatory Affairs Manager Becton, Dickinson and Company People's Republic of China |
Regulatory Authority | |
Member: | Eng. Sahar Almalki Scientific Evaluation Expert Saudi Food and Drug Authority Kingdom of Saudi Arabia |
Regulatory Authority | |
Member: | Ms. Jie Li Reviewer Center For Medical Device Evaluation, NMPA People's Republic of China |
Regulatory Authority | |
Member: | Ms. Gudula Sabina Mpanda Principal Medical Devices Officer Tanzania Medicines and Medical Devices Authority Tanzania |
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Member: | Mr Sharad Manasvi Shukla Director Regulatory Affairs, MedTech Johnson & Johnson Medical Singapore |
Industry | |
Member: | Ms. Nasreen AlQuaid Staff Regulatory Affairs Specialist Becton Dickinson USA |
Industry | |
Member: | Mr. Inho Dan Sr. Quality and Regulatory Affairs Manager - ANZ, Emerging Asia and Korea Cordis Korea Ltd Republic of Korea |
Industry | |
Member: | Ms. Qiong Wu RA Director Johnson and Johnson Medical (Shanghai) Ltd People's Republic of China |
Industry | |
Member: | Ms. Hana Lee RA Manager Mindray Korea Republic of Korea |
Industry | |
Member: | Ms. Jean Lei Regulatory Affairs Manager Shenzhen Mindray Biomedical Electroics Co. Ltd People's Republic of China |
Industry | |
Member: | Ms. Jing Crystal Nie Director Regulatory Affairs & Regulatory Compliance (China) MicroVention Inc.,subsidiary of Terumo Corporation People's Republic of China |
Industry | |
Member: | Dr. Huiying LI Associate RA Director Medtronic People's Republic of China |
Industry | |
Member: | Ms. Fang LYU Sr. RA Director Medtronic Greater China People's Republic of China |
Industry | |
Member: | Mr. Hirokazu Fukuda Member of Regulatory Affairs Group FUJIFILM Healthcare Corporation Japan |
Industry | |
Member: | Mr. Tao Wu Prin. RAS Medtronic (Shanghai) Management Co., Ltd People's Republic of China |
Industry | |
Member: | Ms. Kazuko Ueki Associate Director, Regulatory Affairs, Asia Pacific Johnson & Johnson K.K. Japan |
Industry | |
Member: | Ms. Makiko Kuroki Assistant Manager Asahi Kasei Medical Co., Ltd. Japan |
Industry | |
Member: | Ms. Tiffany Lin QA/RA Manager UROMEDTECH PTE LTD Singapore |
Industry | |
Member: | Ms. Wella Wei China RAQA Director Align Technology Co. Ltd. People's Republic of China |
Industry | |
Member: | Dr. Yassmin Eltalawi Regulatory Intelligence Manger - EMEA Becton Dickinson Dubai-UAE |
Industry | |
Member: | Mr. Chidae Park HQ Regulatory Affairs Managing Director Lutronic Corpation Republic of Korea |
Industry | |
Member: | Ms. Sin Yi Chong Regulatory Affairs Executive Osteopore International Pte Ltd Singapore |
Industry | |
Member: | Ms. Heli Liu Regulatory Affairs and Quality Assurance, Senior Director, APAC Align Technology People's Republic of China |
Industry | |
Member: | Ms. Jie Jiang Executive of Regulatory & Regional Quality GE Healthcaer People's Republic of China |
Industry | |
Member: | Ms. Lei Wu Sr. RA Manager Venus Medteach (Hangzhou) Inc. People's Republic of China |
Industry | |
Member: | Dr. Xiaowei Sun Head of Regulatory Affairs, Greater China Philips People's Republic of China |
Industry | |
Member: | Ms. Heejin Choi Regulatory Affairs Manager, Country 3M Healthcare Korea Republic of Korea |
Industry |
Guidance Documents:
FINAL_GHTF SG1 Definition of the Terms
FINAL_GHWP_WG_Proposed_Final_Comb_ Prod_Guidance-241116
Work Plan and Target:
GHWP_TC_WG01_Work Plan 2012-2014