Alexander Roussanov
Europe Guide 2024
Band 3 : Life Sciences: EU
Email address
[email protected]Contact number
+32 (0)2 290 7853Share profile
Band 3
About
Provided by Alexander Roussanov
Practice Areas
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.
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.
Chambers Review
Europe
Head of department Alexander Roussanov assists international clients with EU-wide regulatory compliance mandates and disputes over marketing authorisations.
Strengths
Provided by Chambers
"Alexander is an excellent partner. He is incredibly knowledgeable and pragmatic, and I always feel he provides me with top-notch guidance."
"We truly enjoy working with Alexander. He is always responsive and provides thoughtful advice to every member of our team."
"Alexander is pragmatic and available, and describes complex things in an easy way. He says things like they are."
"Alexander is truly a pleasure to work with on various matters. He is very good at explaining issues and getting us to a resolution quickly. He knows business well and is very responsive to evolving business needs."
"Alexander Roussanov is a wonderful, helpful lawyer. With the work he has done for us, I couldn't endorse him any more highly."
"Alexander is an excellent partner. He is incredibly knowledgeable and pragmatic, and I always feel he provides me with top-notch guidance."
"We truly enjoy working with Alexander. He is always responsive and provides thoughtful advice to every member of our team."
"Alexander is pragmatic and available, and describes complex things in an easy way. He says things like they are."
"Alexander is truly a pleasure to work with on various matters. He is very good at explaining issues and getting us to a resolution quickly. He knows business well and is very responsive to evolving business needs."
"Alexander Roussanov is a wonderful, helpful lawyer. With the work he has done for us, I couldn't endorse him any more highly."