What Risks Does EU (536/2014) Pose To Your Trials?

In January 2022, major changes came to the way clinical trials are conducted in the European Union. EU (536/2014) came into effect and is a binding regulation across all members of the EU. The new regulation will streamline procedures and remove duplication single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirement.

However, there are issues sponsor companies should be concerned about. Check out this On-Demand presentation from Clinical Leader Live to learn about the shortcomings of the regulation, challenges that can arise from it, how technology solutions can play a greater role in trials, why the regulation will require coordinated efforts, and what companies can do to avoid delays in the launch of multi-country clinical studies.