Duration: 1 day

Description:

This course covers the key aspects of IND requirements which are relevant for an IND study in European sites.

Who it is suitable for:

Those involved in conducting clinical trials in Europe 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 in Europe

Key differences between US and EU requirements

• FDA forms
• FDA Inspections