Module 5 Presentations

05/07/2024

In this session we will cover

1. Introduction on Legislation 2. CTA Submissions under CTR 3. CTA Maintenance (comparative review CTD / CTR) 4. Getting ready for the EU Clinical Regulation • Impact considerations

• Readiness considerations 5. Transition considerations

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

3

1. Introduction on Legislation

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

4