Module 5 Presentations

05/07/2024

Learning Outcomes

• Understand the purpose of development of Good Clinical Practice (GCP)

• Objectives & Principles of GCP

• The techniques for monitoring and assurance of GCP

The Organisation for Professionals in Regulatory Affairs

3

In this presentation we will cover

• History, objectives and basic principles of GCP • Quality & Compliance & Audits & Inspections • Fraud & Misconduct in clinical research • Case studies & Examples

The Organisation for Professionals in Regulatory Affairs

4

2