The EU Clinical Trials Regulation


The intended harmonization of the legal framework for research with medicines involving humans within the EU by the Clinical Trials Directive 2001/20/EC was not fully reached. As a result, Europe did not become as attractive a region to conduct clinical trials as expected. Partly thanks to the pressure of different stakeholders, the EU Clinical Trials Regulation 536/2014 (CTR) was created and adopted in 2014 to replace the Directive, aiming to turn the tide.

However, the CTR will only become applicable in all EU member states as of 2019. Why the delay? What changed and how big will the impact be?

In this TRIUM Session, you will learn all about the ins and outs of the CTR, the expected progress versus the repealed Directive, and the status of its implementation in Belgium. As a result, you will gain a better insight into whether the CTR indeed will make Europe, and especially Belgium, an even more attractive region and country to conduct clinical trials with innovative human medicines.

At the end, you will receive a certificate and handy hand-outs for later use.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Describe the key components of the EU Clinical Trials Regulation
  • List the main differences between the CTR and the Clinical Trials Directive
  • Provide an update on the CTR implementation in Belgium
  • Critically assess the foreseen benefits of the CTR for the EU region, and particularly Belgium
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.