Duration: 1 day

Description:

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.

Example content:

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 forms
• FDA Inspections

FDA requirements for acceptance of data from non-IND foreign clinical trials