Ensuring privacy compliance in pharma sector

As the appointed Data Protection Officer for a U.S.-based biotechnology company preparing to initiate clinical trials within the European Union, our team collaborated closely with internal clinical, medical, and legal departments, as well as the designated Contract Research Organization (CRO).

The project focused on reviewing and updating all country-specific Informed Consent Forms (ICFs) from a data privacy perspective to ensure full compliance with both local regulations and overarching EU data protection requirements, including the General Data Protection Regulation (GDPR). This work spanned multiple jurisdictions, specifically the Czech Republic, France, Germany, Hungary, Poland, Spain, and the United Kingdom.