Module 5 Presentations

05/07/2024

Suggested readings

• ICH E6 (R2 and draft R3) Guideline for Good Clinical Practice • European Commission and EMA pages on Clinical Trials • Directive 2001/20/EC • Regulation (EU) No 536/2014 • CTIS Transparency Rules (EMA/263067/2023)

• EudraLex - Volume 10 Clinical trials guidelines (CTR and CTD pages) In particular the Commission Q&A available for each framework (CTD / CTR). Latest update: March 2024 (update pending) • EMA website: CTIS training pages, Sponsor Handbook, other supportive info • CTIS Landing page: https://euclinicaltrials.eu/home In particular Release Notes and List of Know Issues under menu entry ‘Support’

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

57

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)

58