Georgia Gavriilidou LLM

Georgia Gavriilidou advises clients on all aspects of EU and UK regulatory law. During Georgia’s career, she spent eight years at the European Medicines Agency (EMA). As a senior legal adviser, she was instrumental in leading the implementation of major pharmaceutical legislation such as pharmacovigilance (including the Pharmacovigilance Fee regulation) and Advanced Therapies legislation. In parallel, she was the principal legal adviser on a plurality of pharmaceutical issues relating to fixed-dose combination medicinal products, orphan and pediatric medicinal products, transfer of marketing authorizations, parallel distribution, invented names and validation/pre-authorization issues. Georgia successfully represented the EMA before the European Courts on pharmaceutical and procurement cases.

Georgia has extensively advised bio/pharma medicinal companies on the lifecycle management of bio/pharma medicinal products, including the maximization of IP regulatory rights (such as regulatory data protection, orphan exclusivity, and SPC). She coordinated EU-wide legal advice, which included drafting submissions to regulatory authorities across the EU, advising and representing clients on litigation strategy before the national authorities, the UK and EU courts, as well as interpreting the EU pharma legal framework.

Georgia has assisted companies on market access issues, including advising on Health Technology Assessment (HTA) issues, as well as challenging a NICE Decision before the English courts on behalf of a leading French pharmaceutical company. She has also advised companies on the advertising and promotional legal framework applicable to medical devices and medicinal products, including assisting in proceedings before the PMCPA.