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Clinical Trial Events
SCOPE Summit 2027

Talk AI in Clinical Research track

From Evidence Generation to Regulatory Review: Enabling AI in Regulatory Activities

Tue, Mar 2, 2027 · 11:30–11:55 AM EST Rosen Shingle Creek

About this session

Artificial intelligence (AI) is reshaping how evidence is generated, assessed, and reviewed in clinical research. This presentation will explore the regulatory environment needed to enable AI-enabled evidence generation and the growing use of AI by regulators to support regulatory activities and review. It will consider near-term opportunities for AI-assisted approaches, the role of human oversight and accountability, and the need for fit-for-purpose, risk-based frameworks and greater global regulatory convergence.

Speaker

  • Hussein Ezzeldin

    Division Director, Division of Artificial Intelligence, Office of Innovation and Clinical Trial Modernization, Office of Medical Policy, CDER · FDA

    Speaker