This session offers a potpourri of various international data initiatives that aim to transform the way medicines are developed, regulated and used in clinical practice. The main question we will try to get answered during this session is: How do we enable and use data for clinical and regulatory decisions? From the ambitious European Health Data Space (EHDS) and virtual humans (VHP4Safety) initiatives to the newly developed European medicines regulatory database (EMRD): we will dive into the foundations of clinical and regulatory decision making, and the world that eventually feeds artificial intelligence.