Hélène Casaert is pharmacist by background, specialised in the regulation of medicines in the European Union.
She worked in regulatory affairs in the pharmaceutical industry and was in charge of compassionate use program in oncology, registration activities and clinical trial applications in virology and immunology. She also worked for the French National competent authority (ANSM) in the clinical trials sector as an assessor before joining the EMA in 2015.
She now works as a scientific officer within the SME office at EMA, providing dedicated support to SMEs developing medicines in the EU and supporting innovation.