Helene Casaert is a regulatory affairs professional with over a decade of experience in the European medicine’s ecosystem. Trained as a pharmacist, she has held several roles in both the pharmaceutical industry and public sector, including regulatory affairs and clinical trial oversight at the French national competent authority. Since 2015, she has been working at the European Medicines Agency (EMA), where she currently works as a scientific officer in the SME Office. In this role, she provides strategic regulatory guidance and tailored support to small and medium-sized enterprises (SMEs) developing innovative medicines in the EU, helping to navigate complex regulatory pathways and accelerate access to patients.