Marcos Fernandez Gomez

Master Data Manager - PMS Product Owner at European Medicines Agency (EMA)

Speaker

Regulatory Affairs and Master Data Management professional with over 10 years of experience in the pharmaceutical industry, specializing in IDMP, xEVMPD, Regulatory Information Management (RIM), eSubmissions, and data governance. At ASPHALION, I led global regulatory transformation projects, including RIM system implementations, data migration, IDMP readiness, xEVMPD compliance, and eCTD submissions for international pharmaceutical companies. Since 2020, I have been working at the European Medicines Agency (EMA) as PMS Product Owner and xEVMPD Business Lead, driving the evolution of medicinal product master data services, API integrations, data quality initiatives, and EU-wide implementation of ISO IDMP standards.