SESSION I – CLINICAL TRIALS
AI, RWE and new regulations: simplify and innovate to make Italian clinical research more competitive
SALA DEL CASTELLO 1
15:15-18:15

The session explores the role of Artificial Intelligence, Real World Evidence, and new regulatory developments in strengthening the competitiveness of Italian clinical research. The impacts of the European AI Act and national legislation on the application of AI in clinical trials will be analyzed. An update will be dedicated to the development of information systems and regulatory provisions supporting RWE. AIFA will offer its perspective on the evaluation of studies and data generated through AI. The session will conclude with a multi-stakeholder round table focused on technological innovation, regulatory simplification, and the attractiveness of the Italian research system.