European Union Clinical Trials Directive

The European Union (EU) Clinical Trials Regulation covers clinical trials in the EU and sets forth requirements of investigators, sponsors, EU Member States’ Competent Authorities, and others responsible for clinical trial regulation. Topics in this course include: Requirements and Responsibilities, Overall Authorization, Modifications and Amendments, IMPs, and Adverse Events. After completing this course, learners will be able to identify the principal elements of the EU Clinical Trials and Good Clinical Practice Directives.

After this course learners will be able to identify the principal elements of the eu clinical trials regulation and good clinical practice directive.