Privacy Puzzle: EU & UK CLINICAL TRIALS: Are you clear on your data protection and legal representation requirements?

Expanding clinical trials into the EU and UK creates new opportunities for sponsors but also brings complex data protection and legal requirements.

Under the EU Clinical Trials Regulation (CTR), sponsors without an EU establishment must appoint a clinical trial legal representative as part of the submission process. The same obligation applies to EU medical device and in vitro diagnostic device (IVD) performance studies conducted under the Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR).

In addition, organisations are typically required to appoint a Data Protection Representative (DPR) under the GDPR, with comparable requirements under UK clinical trial and data protection laws.

While both a legal representative and DPR are essential, they serve distinct purposes and are frequently misunderstood or treated as interchangeable.

Join experts from The DPO Centre and DLRC Group to understand how to remove friction from your application process and ensure both your legal and data protection framework is right first time. Hear directly from specialists with extensive experience advising sponsors across multi-jurisdictional trials.

You’ll learn:

• When you need a clinical trial or device trial legal representative and the key role and responsibilities involved
• When you need a DPR, and how this can impact trial timelines
• The common pitfalls of trial set-up, and how to ensure you meet both clinical and data protection requirements

This session will close with a live Q&A, giving you the opportunity to ask questions specific to your trial study and sense-check your approach. If you are entering into EU or UK trials, this is a session you do not want to miss.

Register here