SESSION VI – REGULATORY
AI supporting the pharmaceutical sector from development to the commercialization of medicines

Pharmaceutical science, technology, and regulation in a present future where human intelligence and artificial intelligence collaborate for health

SALA DEL CASTELLO 2
09:00-13:00 – 15:15-18:30

The program illustrates how artificial intelligence is transforming the entire drug lifecycle, from preclinical research to regulatory assessment and compliance. Practical cases will be presented in which AI accelerates the discovery of new molecules, improves the prediction of efficacy and safety, and supports the design of clinical trials. There will be technical and scientific contributions from academic, industrial, and regulatory experts to highlight opportunities, risks, and limitations in the adoption of AI. A significant part is dedicated to the evolution of the European regulatory strategy on AI, including the impacts of the AI Act on quality, auditability, and data integrity. The program concludes with a roundtable discussion aimed at defining future prospects and priorities for integrating AI as a strategic lever for regulatory innovation.