Seminar 2026

Regulatory agencies are rapidly advancing their thinking on AI in clinical trials, but expectations are still evolving across regions and use cases. That uncertainty is showing up in differing validation standards, documentation requirements, and thresholds for accepting AI in regulated decision-making. Attendees will hear: How FDA, EMA, and MHRA are currently approaching AI in clinical trials and where guidance is converging or diverging What regulators expect in terms of validation, transparency, and auditability for AI-driven tools Where regulatory ambiguity still exists and how agencies are thinking about risk, oversight, and enforcement