Beatriz Silva Lima has more than 20 years of experience as an expert in nonclinical and regulatory science at the Portuguese Medicines Agency (Infarmed) and at the European Medicines Agency. Until 2012 she was a member of the Committee of Human Medicines (CHMP), Committee of Advanced Therapies (CAT) and Scientific Advice Working Party (SAWP). She acted as the Portuguese (Co)Rapporteur of multiple centralized applications and as coordinator of a several European Scientific Advices/Protocol Assistance. She was Chair of the Safety Working Party (SWP) for 12 years, co-Chaired the EMA Nonclinical Expert Group on Nanomedicines and was involved as Co-Deputy in ICH discussions on behalf of the European Commission. Since October 2012 she advises on nonclinical drug development strategies and from 2014 to 2018 she Chaired the Scientific Committee of the Innovative Medicines Initiative (IMI). Beatriz Silva Lima is a Full Professor of Pharmacology at the Faculty of Pharmacy of University of Lisbon (FFUL) and is highly involved in international education in the area of regulatory science. She coordinates a Master Course on Regulatory Science at FFUL; co-coordinates a Nonclinical Module on Regulatory Guidelines of the European Master Course SafeSciMet; integrates the PharmaTrain Course EUDIPHARM (Université Claude. Bernard /Lyon, France) and contributes to the Atrium Regulatory Course on Regulatory Aspects in Denmark as well as to the MIND course of the Copenhagen University. Beatriz Silva Lima integrates the EUPATI (European Patient Academy for Therapeutic innovation) Portuguese Platform is a member of EUPATI’s Steering Committee of the European National Platform and has been co-chair of its Executive Committee.