NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Xavier Luria, MD

Practice Area Focus

  • EU Regulatory Strategy
  • Drug Development Strategy
  • Benefit-Risk Assessment
  • Pharmacovigilance
  • Drug Safety
  • Medical Affairs

Xavier Luria, MD is former Head of Safety and Efficacy at the European Medicines Agency (EMA) where he coordinated regulatory teams from the 27 European Member States in order to evaluate medical products for the whole European Union. He was in charge of several cross-agency projects, including implementation of electronic submissions using eCTD and development of other IT tools, review and reorganization of CHMP's Working Parties, and new methodologies on Benefit/Risk assessment. Prior to joining the EMA, Dr Luria worked as International Medical Director and Head of Research at Almirall (Barcelona) and held positions in clinical medicine at several clinics including the National System of Health. He received his degree in Medicine and Surgery from the Autonomous University of Barcelona, is a member of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom, and did postgraduate studies in clinical pharmacology and drug development and regulation at Tufts University School of Medicine & Tufts Center for the Study of Drug Development (Boston).