Arnold & Porter announced today that Alexander Roussanov has joined the firm's highly ranked Life Sciences & Healthcare Regulatory practice as a partner, resident in Brussels.
Mr. Roussanov formerly served as a senior legal adviser in the Legal Department of the European Medicines Agency (EMA). He focuses on a broad range of issues related to the life-cycle of medicinal products and medical devices, including product classification, clinical trials, marketing approvals, pharmacovigilance and device vigilance, marketing and promotion, and interactions with health care professionals. He has particular experience in certain EMA-specific matters including the rules surrounding advanced therapy medicinal products, marketing authorization procedures, referral procedures, GxP inspections, freedom of information policy and clinical data transparency. 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. In addition, he has represented the EMA in litigation in the Court of Justice of the European Union. Mr. Roussanov also has experience in internal investigations, audits and regulatory due-diligence projects.
Ian Dodds-Smith, co-head of Arnold & Porter's Food, Drug and Medical Device practice in Europe, said: "Alexander is a well-regarded lawyer in the field of life sciences. His background and first-hand experience in dealing with sensitive and complex regulatory matters at the EMA, coupled with his experience in private practice, will enhance our offering in this important regulatory field. He is well-positioned to help clients navigate business challenges in a rapidly changing and uncertain global regulatory environment in Europe."
Mr. Roussanov said: "I am thrilled to be joining Arnold & Porter's pre-eminent Life Sciences team. The firm's sophisticated regulatory practice and ability to handle the most complex, high-stakes issues faced by their life sciences clients makes the firm the ideal platform to expand my practice and serve clients in today's highly regulated environment."
Mr. Roussanov earned his MA in Belgian Public and Private Law from the Université Libre de Bruxelles; MA in European political and administrative studies from the College of Europe; and DESS in European Communities Litigation from the University of Strasbourg.