Elvira Falco is the Head of Regulatory Affairs, Roche Farma, S.A. Spain and is responsible for the supervision and co-ordination of the regulatory activities for this affiliate. She joined Roche in June 2016, and before that she gained her regulatory expertise at Lilly, where she worked since she has completed her specialization in Regulatory Affairs with the Master Degree of Science in Regulatory Affairs at the Universidad Autónoma of Barcelona in 2003. During her professional experience she has gained broad training, knowledge and experience in the field of pharmaceutical regulation and pharmacovigilance of medicinal products (biologics and non-biologics registered through Centralized/ Decentralized/Mutual Recognition or National procedures, for a broad variety of therapeutic areas). She is an active participant of the Regulatory and Expert Network groups of the FARMAINDUSTRIA and Pharmaceutical Industry Associations (AEFI; AMIFE; RAPS) participating as lecturer at many national and international professional events. “The combination of deep regulatory knowledge and critical thinking is powerful” ― Elvira Falco