AQC Members Only - AI, Quality, and ICH E6(R3): From Principles to Practice

Wednesday, September 30, 2026, 10:00 AM - 3:00 PM

As artificial intelligence becomes increasingly integrated into clinical development, organizations must ensure implementation aligns with the quality, risk-based, and oversight principles outlined in ICH E6(R3). This interactive summit will explore how to apply AI within a fit-for-purpose quality framework, from governance and inspection readiness to protocol design, critical-to-quality factor identification, and process-level risk management.

Through expert presentations and hands-on workshops, participants will have the opportunity to compare AI-enabled approaches with traditional methods, evaluating differences in efficiency, consistency, risk identification, and decision making. Whether embracing AI tools or applying established practices, attendees will gain practical insights into how quality, oversight, and risk management principles can be applied to support inspection readiness and strengthen trial execution across the clinical trial lifecycle