Special Task Group (STG) - Common Evaluation Reliance Practice (CERP)
Special Task Group (STG) - Common Evaluation Reliance Practice (CERP) | ||
|---|---|---|
| Chair: |
Email: zhangsq@cmde.org.cn | Regulatory Authority |
| Co-Chair: |
Email: asmaa.awad@roche.com | Industry |
| Advisor: | Ms. Alicia Chang (Zhang Li) Lead for China APACMed People's Republic of China | Industry |
| Advisor: | Mr. Naoki Morooka Senior General Manager, Medical Regulatory Policy Department Shimadzu Corporation Japan | Industry |
| Member: | Mr. Ishibashi Kenichi Senior Scientist Pharmaceuticals and Medical Devices Agency Japan | Regulatory Authority |
| Member: | Dr. Yokoyama Yoshimasa Principal Reviewer Pharmaceuticals and Medical Devices Agency (PMDA) Japan | Regulatory Authority |
| Member: | Ms. Aidahwaty M. Olaybal Director, Pre-Market Control Medical Device Authority, Ministry of Health Malaysia | Regulatory Authority |
| Member: | Ms. Norlela Hatta Antah Director, International Affairs and Industry Facilitation Division Medical Device Authority, Ministry of Health Malaysia | Regulatory Authority |
| Member: | Ms. Heba Tork Regulatory & Quality Manager North Africa Roche Diagnostics Egypt | Industry |
| Member: | Ms. Bo Gao Policy and Intelligence Director Roche People's Republic of China | Industry |
| Member: | Mr. Inho Dan Sr. Quality and Regulatory Affairs Manager for ANZ, Korea and SEA Cordis US Corp Republic of Korea | Industry |
| Member: | Ms. Jing (Kate) Liu Director Bluesail Surgical People's Republic of China | Industry |
| Member: | Ms. Jing Hu QT Director Siemens Shenzhen Magnetic Resonance Ltd. People's Republic of China | Industry |
| Member: | Ms. Jing Liu Regulatory Affairs Director Well Lead Medical Co., Ltd. People's Republic of China | Industry |
| Member: | Mr. Jiunyan Johnny Wu Medical device evaluation engineer Industrial Technology Research Institute, Chinese Taipei Chinese Taipei | Industry |
| Member: | Mr. Justin Yea RAQA Sr. Program Manager Medtronic Korea Ltd. Republic of Korea | Industry |
| Member: | Ms. Li Li Senior Regulatory Affairs Director Medtecx Co. Ltd. People's Republic of China | Industry |
| Member: | Ms. Liqin Li Associate Director, Clinical Affair & Regulatory Affair Stryker (Beijing) Healthcare Product Co.,Ltd People's Republic of China | Industry |
| Member: | Ms. Nianci Xu Clinical Evaluation Specialist Micro-Tech (Nanjing) Co. Ltd. People's Republic of China | Industry |
| Member: | Ms. Qiuyun Zhao Senior Regulatory Affairs Specialist Elekta Beijing Systems Co. Ltd. People's Republic of China | Industry |
| Member: | Ms. Rui Wang RA & CA Director Sino Medical Science Technology Inc. People's Republic of China | Industry |
| Member: | Ms. Sally Chiu MDR Executive Secretary Medtecx Co. Ltd. Chinese Taipei | Industry |
| Member: | Ms. Tiantian Yang Regulatory Supervisor BSC International Medical Trading (Shanghai) Co., Ltd People's Republic of China | Industry |
| Member: | Mr. Xuelai Wang CEO SCW Medicath Ltd People's Republic of China | Industry |
| Member: | Mr. Yihua Cao Regulatory Affiars Asahi Kasei Medical Co., Ltd Japan | Industry |
| Member: | Mr. Yi-Shin Lee Vice President Bioteque Corporation Chinese Taipei | Industry |
| Member: | Ms. Yujia Guo Sr. Manager Cordis (Shanghai) Medical Devices Co., Ltd. People's Republic of China | Industry |
| Member: | Ms. Yun Jung Choi General Manager Samsung Medison Republic of Korea | Industry |
| Member: | Ms. Hye Jeoung Lee Sr. Project Manager Synex Republic of Korea | Industry |
| Member: | Ms. So Eun Park Regulatory Affairs Lead Philips Korea Republic of Korea | Industry |
| Member: | Mr. Alan Chang General Manager Sturdy Industrial Co.,Ltd Chinese Taipei | Industry |
| Member: | Mr. Sharad Manasvi Shukla Director Regulatory Affairs, MedTech Johnson & Johnson Singapore | Industry |
| Member: | Ms. Chrissy Huang Head of Regulatory Affairs, Emerging Market Ascensia Diabetes Care Singapore | Industry |
| Member: | Ms. Ping Wang Sr. RA Manager ResMed Beijing (Trading) Co. Ltd People's Republic of China | Industry |
| Member: | Ms. Xiaoyang Li RA Manager Johnson & Johnson AMO (Shanghai) Medical Devices Trading Co. Ltd. People's Republic of China | Industry |
| Member: | Ms. Yunmeng Zheng Associate Director, Regulatory Affairs Johnson & Johnson Medtech China People's Republic of China | Industry |
| Member: | Ms. Wei Ping Kong Associate Director, Regulatory Affairs Johnson & Johnson Vision People's Republic of China | Industry |
| Member: | Ms. Wen Peng Sr. Director, Regulatory Affairs and Clinical Sciences, Greater China Edwards (Shanghai) Medical Products Co., Ltd. People's Republic of China | Industry |
| Member: | Ms. Shaoying Wang Sr. Regulatory Affairs Director bioMérieux (Shanghai) Company Limited People's Republic of China | Industry |
| Member: | Mr. Qinghai Meng Associate Regulatory Director Baxter Healthcare Trading (Shanghai) Company Ltd. People's Republic of China | Industry |
| Member: | Ms. Grace Sun Director RAQA Dawn Medical technologies (Singapore) Pte. Ltd. Singapore | Industry |