Lessons on the EU-Clinical Trials Regulation

The EU Clinical Trial Regulation 536/2014 (EU-CTR) has replaced the EU Clinical Trial Directive 2001/20/EC (EU-CTD). Designed to improve the EU’s competitiveness in the drug development market by increasing transparency, collaboration, and harmonization within clinical trial processes. It holds considerable potential benefits, but it also carries enormous practical implications for anyone who conducts clinical trials in the EU. Thus, all industry stakeholders should start to examine some of its main objectives and plan for ongoing, comprehensive training initiatives to understand its impact.

While it is essential to grasp the EU-CTR's operational implications, companies should also pay close attention to the underlying themes of transparency and collaboration interwoven throughout the regulation. The past few years have demonstrated just how much industry stakeholders—not to mention patients and caregivers—crave harmony and transparency. Indeed, patients and caregivers worldwide are now leveraging technology to come together and demand more openness from sponsor companies and regulatory agencies alike. In many ways, the EU-CTR’s attempts to promote harmony and transparency may set the stage for a very real and very positive paradigm shift in clinical research.

This session will give practical regulatory considerations when planning and conducting a clinical trial in Europe. The CRO perspective will present and knowledge share their experiences applying on behalf of sponsor companies and what they have learnt along the way. A session not to be missed.