Alexander Roussanov

Partner, Arnold & Porter

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.

Contributed to

1

The regulation of advanced therapy medicinal products

Practice Notes

This Practice Note introduces and explores the complexity of the regulation of advanced therapy medicinal products (ATMPs). The Practice Note examines the concept of an ATMP, considers the regulation of ATMPs and the application of the regulatory requirements during the development of an ATMP. The note also considers borderline issues, combined ATMPs and exceptions to marketing authorisation requirements for ATMPs. The note applies the ATMP rules to the collection, storage, import and export of cells or tissues, the testing of embryonic stems cells and the manufacture, distribution, import and export of ATMPs. It also assesses the proposed changes in the ongoing reform of the EU’s pharmaceutical legislation concerning ATMPs.

Life Sciences