Alexander Roussanov, a former senior legal adviser in the Legal Department of the European Medicines Agency (EMA), focuses his practice on a broad range of issues related to the life-cycle of medicinal products and medical devices. His experience includes product classification, authorization and conduct of clinical trials for medicinal products and clinical investigations for medical devices, marketing authorization for medicinal products and CE marking of medical devices, pharmacovigilance and device vigilance, marketing and promotion activities, and interactions with health care professionals.

He is well-versed in certain EMA-specific regulations, including those surrounding advanced therapy medicinal products, marketing authorization procedures, referral procedures, GxP inspections, the Agency's freedom of information policy and clinical data transparency. In addition, he has represented the EMA in litigation in the Court of Justice of the European Union.

Mr. Roussanov advises clients on the form and terms of various types of agreements important for the efficient conduct of research activities including clinical study agreements, sponsor's representative agreements, registry agreements and CRO agreements. He also has experience in internal investigations, audits and regulatory due-diligence projects.

He has extensive practical experience in assisting clients in ensuring compliance with the requirements of Regulation (EU) 2016/679 (GDPR). He advises clients concerning many aspects of the GDPR that are of particular importance in the Life Sciences sector. These include the collection and processing of patients' personal health data and genetic data, transfer of personal health data outside the EU and the territorial scope of the GDPR.

Credentials

Education
  • MA, Belgian Public and Private Law, Universit√© Libre de Bruxelles
  • MA, European Political and Administrative Studies, The College of Europe
  • DESS, European Communities Litigation, The University of Strasbourg
Admissions
  • Brussels, Belgium
Languages
  • English
  • Bulgarian
  • French
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