Luca Pani is Professor of Clinical Psychiatry, Department of Psychiatry and Behavioral Sciences, University of Miami, and Executive Director for Global Medical Innovation, NeuroCog Trials, USA. As former Director General of the Italian Medicines Agency (AIFA) and member of the CHMP and SAWP for EMA in London, he is a recognized expert in psychopharmacology, clinical psychiatry and regulatory science with particular emphasis on health technology assessment linked with novel negotiation strategy.