EU Clinical Trials Regulation: The Full Implementation of the EU CTR
Description
This Episode #7 "EU Clinical Trials Regulation: The Full Implementation of the EU CTR" explores the full implementation of the EU Clinical Trials Regulation (CTR) No 536/2014, marking a pivotal shift from the former Clinical Trials Directive (2001/20/EC).
We focus on harmonization, transparency, patient safety and how clinical trials are transformed across the EU.
Key highlights include:
✅ The introduction of the Clinical Trials Information System (CTIS) for streamlined submissions.
✅ Enhanced measures for patient safety and ethical standards.
✅ The role of the ACT EU (Accelerating Clinical Trials in the EU) initiative in supporting smarter, more efficient trials.
✅ New processes for non-commercial sponsors and simplified multi-national trial applications.
United States
