Alexander Roussanov | People

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. He advises clients on product classification, authorization and conduct of clinical trials and clinical investigations, marketing authorization for medicinal products and CE marking of medical devices, pharmacovigilance and device vigilance, marketing and promotion activities, privacy and data protection compliance, and interactions with health care professionals.

He is well-versed in certain EMA-specific regulations, including those surrounding advanced therapy medicinal products, safety referral procedures, GxP inspections, the Agency's freedom of information policy, and clinical data transparency. In addition, Alexander has represented the EMA in litigation in the Court of Justice of the European Union.

He has extensive practical experience counseling organizations on data protection, digital and data security matters. Alexander assists clients with GDPR and e-Privacy Directive matters. This includes matters of particular importance in the Life Sciences sector (e.g., processing of personal health and genetic data, cross border transfers, and the territorial scope of the GDPR).

He also advises clients on the practical implications and requirements of the ever developing EU digital legislation, including the EU AI Act, the European Health Data Space, the EU Data Act, and the NIS2 Directive.

Alexander also 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.

Focus Areas

Experience

Assisting Pfizer jointly with BioNTech in seeking to intervene in proceedings in Case T-96/21 Amort, concerning an application for the annulment of an EU conditional marketing authorisation for a COVID-19 vaccine.
Providing strategic advice to a trade association on potential pathways for obtaining relaxation of timelines for submission of the applications for paediatric SPC extension in light of delays in the conduct of paediatric clinical trials in the context of COVID-19.
Advising global pharmaceutical company on the EU and national rules governing the automated bedside decentralised manufacturing of centrally authorised ATMPs.
Assisting biotech companies in their pre-approval discussions with the EMA (e.g., ITF, scientific advice, protocol assistance) and matters relating to product classification.
Regularly assisting clients in their interactions with Ethics Committees, EU Member States competent authorities in relation to the approval, conduct and GCP compliance of clinical trials, as well as the drafting and negotiation of clinical trials agreements, master services agreements with vendors and clinical trial documentation (e.g., ICFs).

Advising multiple clients on unlicensed use/compassionate use schemes and other market access issues.
Providing strategic assistance and advice to clients in their regulatory interactions with the EMA (e.g., applications for marketing authorisation, PSUR submissions, safety referrals, post-marketing obligations).
Assisting numerous clients in responding to GxP inspections by the competent authorities in the EU.
Developing and reviewing internal compliance documents for various pharmaceutical companies and medical devices manufacturers.
Advising pharmaceutical companies and medical devices manufacturers ;on compliance of promotional materials and interactions with HCPs, HCOs and patient organisations.
Assist multiple clients in complying with French sunshine law and anti-gift law requirements (e.g., prior notification/approval of agreements with French HCPs).
Provide regulatory advice to a manufacturer of highly innovative implantable medical device, including conduct of clinical investigations and implementation of named patient/compassionate use programs in the EU Member States and the UK.

Advise global consortium on compliance with GDPR and national laws governing access to patient medical records, real-world evidence and patient treatment outcomes.
Regularly advising numerous clients on the processing of personal data in the context of the conduct of clinical trials, including advice on ICFs, controller/processor roles, legal basis for processing of patients’ personal health data, transfers to third countries and notification/approvals to CNIL.
Advising on the implications of the GDPR for companion diagnostics, genetic testing and the cross-border transfer and sharing of patients’ genetic samples and test results.
Assisting numerous clients in the review, drafting and negotiation of data processing agreements and data protection clauses in various types of agreements.
Developing GDPR compliance programs for vast number of clients, including internal and external privacy policies, privacy notices, records of processing activities, training materials and standard operating procedures.

Helping clients ensure GDPR compliance in the design, development, implementation, and marketing of health apps, eHealth solutions and connected medical devices.
Assisting Life Sciences and other companies in the handling, investigation and reporting of personal data breaches.

Advising the Health Outcomes Observatory on the establishment of the H2O platform and related compliance with the GDPR, the EU Data Governance Act and the European Health Data Space.
Assisting a Leading Life sciences global company in the development and implementation of compliance program covering the EU Data Act and the NIS2 Directive.
Advising Global pharmaceutical leader on their compliance with the EU Digital Services Act and their interactions with app store platforms and providers.

Advising a number of leading charities, including Cancer Research UK, Kids in Need of Defense UK (KIND), The Big Give, as well as associations, academic organisations and affinity groups in all aspects of complying with the GDPR and the e-Privacy regulations.