Violeta Stoyanova-Beninska | Senior Scientific Specialist at Human Division EMA, Chair of Regulatory Science Committee, IRDiRC, former Chair of COMP at EMA
EMA

Dr. Violeta Stoyanova-Beninska is a medical doctor with a PhD in molecular genetics and a Master of public health degree. As a regulator and scientist Violeta has dedicated her career to clinical work, research in genetics and regulation of medicines and in particular to therapies for rare and ultra-rare diseases. Violeta has joined the EMA in 2024 as senior scientific specialist at the Human Division of the European Medicines Agency (EMA). Her focus is on rare neurodevelopmental and neurodegenerative disorders, but also on medicines for rare diseases in general. She has been the Chair of the Committee for Orphan Medicinal Products (COMP) at EMA and COMP member representing The Netherlands, member of Central Nervous System working party and Scientific advice working party at EMA. At the Medicines Evaluation Board (CBG-MEB), Violeta has fulfilled various roles, among which Chair of the National Scientific and Regulatory Advice. Violeta is involved in several international initiatives such as ICMRA and IRDiRC. She is the current Chair of the Regulatory Science Committee (RSC) of IRDiRC. Violeta combines her role as regulator with that of an academic. She is guest faculty at several universities, member of editorial board/reviewer for scientific journals, academic supervisor of PhD and master students (co-promoter) at Utrecht UMC and member of PhD committee (promotiecommissie) at Amsterdam UMC.   Violeta has received several awards; the latest one is the EURORDIS Black Pearl Award for Leadership 2025.