Georgia Gavriilidou

I am currently holding the position of the Associate General Counsel (Executive Director) at Amgen coordination the legal strategy on European Level on legal regulatory topics (including medicinal devices, pharmacovigilance, combination products, etc), market access and litigation. In my former role at the EMA, I was the lead lawyer in the implementation of major pharmaceutical legislation including the advanced therapies legislation and pharmacovigilance legislation. I have also served as chief legal adviser on a wide array of pharmaceutical issues relating to fixed-dose combination medicinal products, orphan and pediatric medicinal products, parallel distribution, invented names and validation/pre-authorization issues. My experience also covers counseling clients on life-cycle management of bio/pharma medicinal products, including the maximization of IP regulatory rights and representing clients on legal strategy before the National / EU Authorities, the UK and EU Courts (for EMA and clients).