The Chinese Food & Drug Administration (CFDA) recently passed medical device clinical trials guidelines which will assist in enhancing the administration and oversight of medical device clinical trials in an effort to focus on GCP compliance, the first such regulation passed in over 12 years. Officially titled “Good Clinical Practice for Medical Devices”, the guidance took effect on June 1, 2016 and included an extensive amended set of Good Clinical Practices for device clinical trials conducted in China, including requirements for multicenter trials, informed consent and record-keeping. Medical device companies looking to conduct clinical trials in China must review current practices and protocols to update standards in accordance with the new GCP guidance.
- Detailed review of Chinese GCP standards
- Including new requirements into clinical protocols
- Outlining related clinical and regulatory developments in China
- Updated exemption list
- Site accreditation
- Time tables and budget considerations for successful trials
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Clinical Affairs
- Clinical Research
- Regulatory Affairs
- Quality Assurance
Ms. Angelina Hao is the CEO of Normalline with Master degree of Business Administration (MBA) and Medicine. She has extensive working experiences in Scientific Research and Development in State Research Laboratory, and Production, Quality and Regulatory experience for both American companies and European Companies. With her over 15 years’ experience in R&D management, product transfer, enterprise operation and regulatory management, Angelina co-founded Normalline in 2008, a professional service company to provide Chinese regulatory information, compliance consulting, submission support and relevant management service concentrating on the Medical Devices (MD) and in vitro diagnostics (IVD) industry. The clients are including Johnson&Johnson, Abbott, BD, Medtronic, Boston Scientific, Novartis, Qiagen, Grifols, Alere, Coloplast, STAAR etc. those world-wide known companies. With her extensive experiences and leading management concept in China RA, Angelina is a distinguished expert in Chinese RA and compliance management recognized by the authorities. She is the specially appointed expert by CFDA to train the whole medical device industry since 2010. Normalline was appointed the unique management service company by CMDE (CFDA’s Center for Medical Device Evaluation) to establish the China’s Scientific Evaluation System for Medical Device in 2012.