Smarter Tools, Stricter Rules: Navigating AI guidance and Data Laws in Clinical Trials

Panel Webinar Hosted by AVS Life Sciences - Register HERE

Guest speakers:

Jeanette Towles, CEO and Founder of Synterex, Inc.

Cindy Towers, CEO and Founder of JURISolutions Legal

Nikoo Arasteh, QA Director, Jaguar Health

Liea Helmonds, VP Quality, AVS Life Sciences

Abstract (short): Are your AI tools creating new compliance risks in the EU? Join regulatory and legal experts to dive into real-world impact of GDPR and the EU AI Act on clinical trial systems.

Overview:
As artificial intelligence becomes more deeply embedded in clinical development—from data handling to decision support—regulatory professionals must interpret a shifting European legal and ethical landscape. The General Data Protection Regulation (GDPR) and the newly adopted EU Artificial Intelligence (AI) Act are two foundational frameworks shaping how sponsors, CROs, and technology providers develop and deploy AI in the context of clinical trials.

This interactive panel webinar will bring together experts in legal, regulatory, and quality domains to unpack the broader implications of these regulations. Panelists will explore how the GDPR and AI Act intersect, where they diverge, and what they signal about the future of data-driven innovation in life sciences. Through a series of moderated questions, each expert will provide perspective on the responsibilities and risks these frameworks introduce—offering attendees a clearer view of how to navigate compliance while enabling innovation.

What You Will Learn:

• How the GDPR and EU AI Act apply to AI-enabled systems in clinical research

• What the AI Act’s risk-based classification means for tools used in trial oversight and documentation

• Points of tension or alignment between data protection and AI governance

• Legal and ethical considerations surrounding transparency, accountability, and informed consent

• Documentation and QA strategies to support regulatory expectations for AI use

• How to evaluate vendor and system readiness in light of evolving EU requirements

Who Should Attend:
This session is ideal for regulatory affairs professionals, QA leads, legal advisors, clinical operations staff, and sponsors working in or supporting EU-based trials or global trials involving AI-enabled systems.

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