European Union Clinical Trials Regulation (EU CTR)

Ready to leave the slow lane behind? This course on the European Union Clinical Trials Regulation & Registry (EU CTR) will teach you how the EU replaced its confusing, multi-country clinical trial approval system with a streamlined, centralized process. We’ll show you how the new Clinical Trials Information System (CTIS) is the single portal that manages applications, enhances transparency, and reduces administrative burden, transforming the road blocks that characterized the old system into a unified and efficient high-speed race for medical innovation.

This course is your essential guide to navigating the modern EU clinical trial landscape. You’ll explore the features of the EU CTR and how they affect stakeholders, including sponsors, regulators, and patients. From understanding the phased transition from the old Clinical Trials Directive (CTD) to the components of the CTIS, you’ll gain a strong grasp of how EU CTR’s harmonized rules and strict timelines are accelerating research and getting new treatments to patients faster than ever before.