CONDUCTING SUCCESSFUL DEVICE CLINICAL TRIALS IN CHINA UNDER NEW GOOD CLINICAL PRACTICES (GCP) GUIDANCE
Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.
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