This course provides an overview of medical device clinical trial activities and applicable Good Clinical Practices including, FDA 21 CFR 812: IDEs, ISO 14155, ICH GCP E6 Guideline and E6(R2) Addendum. The information presented is ideal for those new to clinical research or those new to medical device industry requiring understanding relating to the regulatory and practical aspects of medical device clinical research.
AGENDA: 8:00 am - 5:00 pm
ADDITIONAL WEB-BASED COURSE ADD-ONS
In Person Training – At IMARC or Your Location
8.0 hours (0.8 CEUs)