This course covers the key aspects of FDA requirements for Clinical Trials.
Who it is suitable for:
Those involved in conducting clinical trials with sites in the US or conducting international trials under FDA regulations , for example, Project Managers, CRAs, CTAs, investigators, study nurses.
Overview of FDA and it’s departments
Overview of Code of Federal Regulations Title 21
Relevant regulations for Clinical Research
FDA Guidelines relating to Clinical Research
When and how CFR applies outside the US
Key differences between US and EU requirements
FDA requirements for acceptance of data from non-IND foreign clinical trials