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Session 9: Trust, but Verify: Governing AI-Enabled Real-World Evidence from Regulation to Rapid Deployment
Session Chair(s)
Lina Titievsky, PhD, MPH
Head of Hepatology Epidemiology, GlaxoSmithKline, United States
Matthew Curtis
Director of Regulatory Affairs, AstraZeneca, United States
As AI and generative tools rapidly reshape how real-world evidence (RWE) is generated and analyzed, regulators, HTA bodies, and specialty organizations are grappling with how to govern these technologies without stifling their potential. This session tackles that challenge from three angles: comparing how regulatory, HTA, and specialty bodies are operationalizing AI governance frameworks for RWE; outlining practical strategies to establish credibility for AI-enabled RWE in regulatory decision-making; and examining real-world results from deploying off-the-shelf generative AI tools—what works, what doesn't, and why human oversight remains essential. Together, these presentations offer a pragmatic roadmap for balancing speed and innovation with the rigor and trust required for high-stakes evidence generation. Attendees will leave with concrete frameworks and lessons learned for governing AI responsibly while still capturing its efficiency gains.
Learning Objective : At the conclusion of this session, participants should be able to: - Describe varied AI governance frameworks for Real-World Evidence (RWE) across regulatory, Health Technology Assessment (HTA), and specialty bodies
- Apply criteria to assess AI-generated RWE credibility for regulatory decisions
- Explain why human oversight is critical for compliant AI deployment in RWE workflows
Speaker(s)
John Diaz-Decaro, PhD, MS
Founder, Black Swan Causal Labs, United States
Operationalizing AI Governance for RWE: A Comparative Analysis of Regulatory, HTA, and Specialty Bodies
Representative Invited
Director, Johnson and Johnson Innovative Medicine, United States
Establish Credibility for AI Enabled Real World Evidence in Regulatory Decision Making: From Promise to Practice
Representative Invited
Director, Business Strategy, IQVIA, United States
Minutes, Not Days: Off-the-Shelf Generative AI in RWE — Works, What Doesn't, and Why Humans Stay in the Loop
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