The AI Compliance Playbook: Navigating EMA and FDA Draft Guidances

Описание: As artificial intelligence becomes increasingly embedded in clinical research, regulators are stepping up with frameworks to ensure its safe and effective use. This panel builds on earlier discussions and dives into the recent draft guidances and position papers from the FDA and EMA, which outline expectations for AI tools used in clinical trials from risk-based credibility assessments to lifecycle governance and transparency. Panelists explore practical controls organizations can implement to align with these evolving standards, and how the principles in these guidances can be applied to real-world clinical trial operations. Whether you're deploying AI for data analysis, patient recruitment, or protocol compliance, this session will help you navigate the regulatory landscape with confidence.

00:00 – Welcome & Panel Introductions
04:58 – Setting the Regulatory Context for AI in Clinical Trials
05:01 – Question 1: How Should AI Be Validated in GxP Environments?
10:29 – Reproducibility, Deterministic vs Probabilistic AI
18:03 – Ethics, Risk-Based Approaches & Patient Impact
22:43 – Governance, AI Hype & When Not to Use AI
24:04 – Industry Frameworks: GAMP, ISPE & Practical Guidance
26:36 – Question 2: Transparency & Explainable AI
30:13 – Question 3: Ongoing Compliance & Model Monitoring
36:01 – Audience Q&A, Key Takeaways & Session Wrap-Up