Alexander Roussanov

Alexander Roussanov

Counsel, Brussels

Email alexander.roussanov@​hoganlovells.com

Phone +32 2 505 0931

Fax +32 2 505 0996

LanguagesBulgarian, English, French

Alexander Roussanov is a counsel of our Life Sciences practice and advises clients on a broad range of issues relating to the EU and national regulatory framework governing the marketing of medicinal products and medical devices.

Through his work in private practice, pharmaceutical companies and the European Medicines Agency (EMA), Alexander acquired extensive first-hand experience in dealing with highly sensitive and complex regulatory matters, access to documents and clinical data disclosure. Building upon this experience, he delivers practical, clear and effective advice to clients in relation to regulatory strategies and interactions with the regulators.

Alexander focuses on a broad range of issues relating the life-cycle of medicinal products and medical devices- product classification, clinical trials, marketing authorisation, CE marking, pharmacovigilance, post-marketing surveillance, marketing and promotion, interactions with healthcare professionals. He also advises clients on EMA-specific issues relating to advanced therapy medicinal products, GxP inspections, access to documents and clinical data publication. Alexander assists Life Sciences Clients in the preparation, drafting and review of clinical study agreements, sponsor's representative agreements, registry agreements, CRO agreements and distribution agreements. In addition, he has been directly involved in internal investigations, audits and regulatory due-diligence projects.

Before joining Hogan Lovells, Alexander served as Legal Adviser in EMA. He litigated successfully four access to documents cases in the General Court. Alexander was also heavily involved in complex and sensitive safety referrals procedures, including referrals that resulted in legal challenges.

Alexander acquired practical in-house experience in leading international pharmaceutical companies. This in-depth understanding of the needs of Life Sciences companies allows him to deliver practical, focused, effective and results-oriented advice to clients.

Education and admissions

Education

M.A. in Belgian Public and Private Law, Université Libre de Bruxelles, 2009

M.A. in European political and administrative studies, College of Europe, 2007

D.E.S.S. European Communities Litigation, University of Strasbourg, 2004

Memberships

Bulgarian Legal Qualification in accordance with Article 163 of the Bulgarian Judicial System Act

Bar admissions and qualifications

Brussels

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