Smarter Tools, Stricter Rules: Navigating AI guidance and Data Laws in Clinical Trials Part 2

Webinar Overview:
Artificial intelligence is increasingly integrated into clinical development, from data management to decision support. Regulatory professionals must navigate a rapidly evolving European legal and ethical landscape. The General Data Protection Regulation (GDPR) and the EU Artificial Intelligence (AI) Act are key frameworks shaping how sponsors, CROs, and technology providers develop and deploy AI in clinical trials.

This interactive panel webinar brings together experts in legal, regulatory, and quality domains to examine the broader implications of these regulations. Panelists will discuss how GDPR and the AI Act intersect, where they differ, and what these frameworks mean for the future of data-driven innovation in life sciences. Through moderated questions, attendees will gain practical insights on responsibilities, risks, and compliance strategies while supporting innovation.

What You Will Learn:

• How GDPR and the EU AI Act apply to AI-enabled systems in clinical research
• The implications of the AI Act’s risk-based classification for tools used in trial oversight and documentation
• Areas of alignment and tension between data protection and AI governance
• Legal and ethical considerations for transparency, accountability, and informed consent
• Documentation and QA strategies to meet regulatory expectations for AI use
• How to assess vendor and system readiness under evolving EU requirements

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

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