Stefano Marino

Senior Consultant at DLA Piper

Speaker

Stefano Marino led the European Medicines Agency (EMA)'s Legal Department from 2013 to April 2024, after a 25-year career in industry as General Counsel and other executive roles.

Prior to joining EMA, he was also the Chair of the EFPIA Trademark Group (2005-2013) and Member of the EFPIA Intellectual Property Committee (1999-2013). At EMA he led all legal activities concerning Policy 0070 on the publication of clinical study reports, Policy 0043 on access to documents and Policy 0044 on conflicts of interests of scientific experts. He provided extensive guidance on the implementation of the Clinical Trial Regulation, the Veterinary Regulation, the Agency's extended mandate in 2022 and the Commission's draft EU Pharma Law Reform. He also served as Data Protection Officer for three years and thus interacted extensively with the European Data Protection Supervisor and national data protection authorities. Stefano represented EMA in legal proceedings before the EU Courts concerning transparency and access to documents, which ended with the CJEU's landmark rulings on clinical data disclosure in 2020. Under his guidance, EMA also prevailed in many proceedings concerning the interpretation of several provisions of EU Pharma Law.

After retiring from EMA, in October 2024 he joined DLA Piper as Senior Consultant. He is the author of several articles concerning medicinal products, transparency and compliance and is a regular contributor to important events and courses on European procedural and substantive law.