Paschalia Koufokotsiou is a Health Policy Officer at the European Commission's DG SANTE, specialising in Advanced Therapy Medicinal Products (ATMPs). In this role, she supports the EMA's Committee for Advanced Therapies (CAT) across the full range of ATMP procedures — from scientific advice and classification to PRIME designation and marketing authorisation assessments.

A recognised expert in the ATMP field, Paschalia led an EU4Health study on the implementation of the Hospital Exemption across EU Member States, overseeing the process from tender specifications through to the publication of the final report in August 2025.

She has been a key contributor to shaping the EU's regulatory landscape for advanced therapies. On the Pharma Package, she was involved from impact assessment through to the political agreement of December 2025, drafting pivotal articles on the definition of gene therapy medicinal products, the hospital exemption for ATMPs and the new centralised ERA for GMO-investigational medicines. She has also contributed to the EU Biotech Act, including provisions on GMO derogations for investigational ATMPs and the establishment of centres of excellence for advanced therapies.

She holds an MSc in Veterinary Epidemiology & Public Health from the University of London's Royal Veterinary College and a degree in Veterinary Medicine from Aristotle University of Thessaloniki.