EU & UK CLINICAL TRIALS: Are you clear on your data protection and legal representation requirements?
16
2:00 PM - 2:45 PM
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.
Speakers
Pippa Scotcher
DPO at The DPO Centre
Pippa is a highly qualified Data Protection Officer with a background in law and specialist expertise in Life Sciences. She combines analytical precision with a pragmatic approach, helping global sponsors navigate the complex intersection of data protection law and clinical trial regulations. Pippa stays at the forefront of international privacy developments, offering valuable insights and guidance that help organisations strengthen accountability and achieve compliance excellence.
Katarzyna Wieckowska
DPO at The DPO Centre
Katarzyna is a highly skilled Data Protection Officer (DPO), specialising in Life Sciences and clinical trials. She works with sponsors at all stages of maturity, supporting the development of practical data protection frameworks across the full trial lifecycle. With a strong background in cybersecurity and personal data management, Katarzyna anticipates challenges and delivers innovative, risk-based solutions that embed effective privacy practices.
Rik Mannix
DPO at The DPO Centre
Rik is a Fellow of Information Privacy with strong expertise across Healthcare and Life Sciences. Working with global sponsors, he develops practical data protection frameworks that meet multi-jurisdictional requirements from trial stage through to market authorisation. With experience across both technology and clinical settings, Rik helps organisations balance innovation with effective risk management, working closely with stakeholders to drive meaningful improvements in data protection practices.
Dr. Wafa Bouaziz
Managing Director of EU & US Affiliates and Chief Regulatory Officer at DLRC Group
Wafa is a global regulatory professional with a PhD in Molecular and Cellular Biology and experience across multiple therapeutic areas. She supports both early and late-stage development programmes, from CTA and IND submissions through to MAA and NDA/BLA approvals. Wafa has led complex global submissions and regulatory interactions with authorities including the FDA and EMA, with particular expertise in orphan drug development.
Kadi Kuuskmae-Perry
Associate Director and Senior Regulatory Consultant at DLRC Group
Kadi has over 18 years of regulatory experience across national authorities, generics companies, and consultancy. Holding a master's degree in Regulatory Affairs (Medicines), she specialises in regulatory strategy, supporting organisations to plan and deliver effective interactions and submissions to achieve key development milestones. With a background spanning early advice through to approvals, Kadi brings a practical, solutions-focused approach to complex regulatory challenges.
Replays
See all
16
2:00 PM - 2:45 PM