This clinical trial audit course is designed to provide training on methods and approaches to plan, conduct and report on different types of audits with examples of practical implementation and discussion of challenges. Recent trends and updates in clinical trial legislation and guidance, increased use of electronic systems in clinical trials as well as implementation of risk management principles are imbedded. The course is a combination of presentations, panel discussions and exercises by an experienced team of auditors and EMA and inspector representatives.
What you will learn
Who should attend?
This course is designed to provide practical training for auditors and regulatory authority inspectors, who are faced with the challenging task of auditing or inspecting clinical trials and related systems. It will also be of interest to those to clinical trial coordinators in a quality role at health institutions. The content may also benefit quality managers performing self-inspections.
At the conclusion of this course, participants should be able to:
Fergus Sweeney, PhD • Head of Inspections and Human Medicines Pharmacovigilance (Division)
European Medicines Agency, European Union, United Kingdom