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

  • 2018-02-28
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)


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