Module 5 Presentations

05/07/2024

TOPRA MSc Module 5

Regulatory requirements for Clinical Trials European Union (EU)

Pierre-Frédéric OMNES Executive Director, TransPerfect Life Sciences July 2024

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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Learning outcomes

• Understanding of the EU Clinical Trial regulatory environment • EU Clinical trial Directive (CTD) and Clinical Trial Regulation (CTR): Comparative overview of main features • Initial submissions under CTR • Maintenance and Close Out activities (CTD / CTR) • Considerations on the CTR post GO Live readiness • Impact assessment and readiness considerations • Points to consider for planning (transition period)

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

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