China Association for Medical Devices Industry (CAMDI) - Latest Schedule! The Medical Device Clinical Trial Seminar 2018 To Be Held in Beijing!

In 2017, China Food and Drug Administration (CFDA) worked to promote medical device classification and standardization, strengthen the supervision and management of clinical trials and implement enterprise’s entity responsibility. All work involving the regulation of medical devices forged ahead steadily. As the rotating presidency of 2018 International Medical Device Regulators Forum (IMDRF), China will encounter a rare opportunity to learn and make improvement in the industry of medical devices.

In order to respond to the issuing of such guidelines as Technical Guidance for Accepting the Overseas Clinical Test Data of Medical Devices and Technical Guidance for Designing Clinical Trials of Medical Devices, China Association for Medical Devices Industry, Innovation Services Committee of China Association for Medical Devices Industry, Medical Device Industrial Technology Innovation Service Alliance, Tianjin Medical Device Technology Innovation Service Center & Covance Medical Research and Development (Beijing) Co. Ltd. and Qiteng Medical Technology Consulting (Shanghai) Co. Ltd. invite leaders and experts from CFDA, Food and Drug Administration (FDA), National Center for Cardiovascular Diseases (NCCD) and famous enterprises to participate in the “Medical Device Clinical Trial Seminar 2018” in Beijing on April 21-22, 2018. Welcome all peers concerned with clinical trials of medical devices to join us. Schedules of this forum:

Time	Topics	Speaker	Position
April 21
9:00-10:00	Update of China medical device regulations and quality improvement of clinical trials for medical devices	Authoritative expert on regulations	National Device Regulatory Agency
10:00-11:00	American medical device regulations and clinical trial management	Mr. Sutton	Assistant Director of FDA China Office
11:20-12:00	Actively embracing reform of medical devices evaluation and approval system in China	Ms. Yin Qiman	Senior Regulatory Officer of Johnson & Johnson (Shanghai) Medical Ltd.
13:30-14:30	Experience of Chinese device enterprises in conducting global multi-center clinical trials	Mr. Kang Xiaoran	Regulatory Director and Registrar General of Sinomedical
14:50-15:50	Clinical trial project management	Mr. Li Wanbo	Operation Director of Clinical Pharmacology of Bayer Medical Co., Ltd.
15:50-17:00	Key points involved in Quality Management Practices for Clinical Trials of Medical Devices	Ms. Yan Jie	Training Director of Qiteng Medical - Covance (APAC)
April 22
9:00-10:00	Analysis and interpretation on Technical Guidance for Accepting the Overseas Clinical Test Data of Medical Devices	Authoritative expert on regulations	National Device Regulatory Agency
10:00-11:00	Analysis and interpretation on Technical Guidance for Designing Clinical Trials of Medical Devices	Professor Li Wei	Director of MRBC-NCCD
11:20-12:00	Medical device innovation and clinical trials oriented by patients and clinical needs	Ms. Chen Xiaojing	Vice President of Clinical/Medical Affairs and Education of Medtronic China
13:30-14:30	Healing the schism: medical devices, clinical trials, evidence-based medicine and statistics.	Mr. Li Qiang	Chief Scientist of Jiutai Pharmaceutical and Medical Device
14:30-15:00	Regulatory filings for medical device clinical trial	Mr. Gao Xin	Director of Plastic Surgery Hospital (Institute), CAMS, PUMC
15:20-16:20	Selecting good partners for clinical trials	Authoritative expert
16:20-17:00	Planning and implementation strategies for global multi-center clinical trials	Mr. Deng Xiaoyu	Business Director of Qiteng Medical - Covance (APAC)

Latest Schedule! The Medical Device Clinical Trial Seminar 2018 To Be Held in Beijing!

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