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How RA/QA Leaders can Optimize AI and Reduce Risk as Industry Moves from the Wild West to its Inevitable Second Phase - Categorization
Session Chair(s)
Nicholas Capman, MBA
President & CEO, The FDA Group, United States
AI adoption in RA/QA is currently fragmented and uncertain, mirroring earlier technology booms like those of the early 2000s. This session explains why AI will inevitably organize into structured categories and how that shift will reshape decision-making and the marketplace. Executives will gain a clear framework for making confident, risk-aware AI decisions now and as the landscape matures.
Learning Objective : Analyze the current AI landscape in RA/QA and explain why AI maturity and market structure are inevitable; Differentiate near-term AI actions, deferred investments, and avoidable risks using a category-driven lens; Apply a practical framework to guide compliant, defensible AI decisions across quality and regulatory functions.
Speaker(s)
Considerations for AI tool validation and implementation
Benjamin Eloff, PhD
Vice President, Healthcare Innovation Catalysts, United States
AI and the Path to Submission Ready RWE: Enabling Compliance and Data Quality
Carrie Nielson, MPH
Director of Epidemiology, Gilead Sciences, United States
Pragmatic AI Deployment in RA/QA: Maximizing ROI While Maintaining Human Control
Fatima Sabar, MSc
Founder and CEO, Bluenote Health, United States
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