Alexander Roussanov
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, privacy and data protection counseling, 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.
He has extensive practical experience counseling organizations on data security and privacy matters. Mr. Roussanov has assisted clients with compliance requirements of Regulation (EU) 2016/679 (GDPR). He advises on 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.
Practice Area
Panel
- Contributing Author
Qualified Year
- 2010
Experience
- Arnold & Porter (2019 - Present)
- Hogan Lovells (2018 - 2019)
- European Medicines Agency (2014 - 2018)
- Hogan Lovells (2009 - 2014)
Education
- Free Brussels University (2009)
- College of Europe (2007)
- University of Strasbourg (2004)
1 Contributions by Alexander Roussanov
PRACTICE NOTES
Advanced therapy medicinal products: EU and UK regulation, classification, clinical trials, manufacturing and authorisation; pharmacovigilance, traceability, GMOs, hospital exemption, and key reforms including SoHO, HTA and UK point-of-care
Advances in medicine, biomicrobiology and biotechnology have given rise to a state-of-the-art group of medicinal interventions that deploy gene therapy, somatic cell therapy and engineered tissues to prevent, manage or even cure human disease. The newness, intricacy and variety of these products has required fresh regulatory instruments, both legislative measures and guidance, to strike an appropriate balance between risks and patient benefits. In the EU and the UK, lawmakers classify this group as ‘advanced therapy medicinal products (ATMPs)’ to safeguard the highest standards of public health while recognising their unique challenges, particularly around clinical trials, manufacturing and pharmacovigilance. Yet oversight of genetically modified organisms (GMOs) used as starting materials for ATMPs remains a national matter and therefore varies from one Member State to the next. These divergences have produced a complicated regulatory environment for ATMPs. Oversight of tissues and cells is likewise presently handled at national level, although such inconsistencies are expected to continue only until 2027, when a revised EU regulation is anticipated to take effect. This Practice Note examines what constitutes an ATMP and how it is regulated, and considers where exceptions apply across clinical trials, manufacturing obligations, pharmacovigilance requirements, and related EU and UK processes today to...
Life Sciences
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