Dalia Dawoud, Manuel Cossio

As artificial intelligence (AI) transforms clinical development and evidence generation, regulators and health technology assessment (HTA) agencies are issuing guidance to ensure that innovation is accompanied by transparency, reliability, and appropriate governance.

What do these evolving requirements mean for your development programs, and how can you navigate them confidently?

Cytel invites you to an interactive Office Hours session where your questions drive the discussion. Examine key guidance and emerging expectations from the FDA, EMA, MHRA, NICE, and other international stakeholders, and what it means for AI applications across real-world evidence generation, decision support, and evidence synthesis.

Questions to consider

• How is the regulatory and HTA guidance on the use of AI evolving?
• What methodological, governance, and evidence requirements should sponsors consider when using AI?
• How can we explore emerging expectations for transparency, validation, and bias mitigation within AI?
• What are some of the practical strategies for generating evidence that supports both regulatory approval and HTA decision-making in an AI-enabled environment?

Speakers

• Dalia Dawoud, Research Principal, HTA Policy and Strategy,
• Manuel Cossio, Head of AI Solutions, Real-World Evidence, Value, and Access