Module 5 Presentations

18/07/2024

Regulatory Requirements for Clinical Trials -Drugs: US and Canada

Sarah Roberts, Vice President, Global Regulatory Clinical Services ICON Operational Delivery

1

Learning Outcomes

 United States ● Brief overview of FDA organisation ● FDA IND filing process ● IND lifecycle ● Ethics Committeereview  Canada ● Brief overview Health Canada organisation ● CTA filing process ● Ethics Committeereview

The Organisation for Professionals in Regulatory Affairs

2

1