HÉLÈNE BOLAND advises clients on EU and Belgian regulation of medical devices and medicinal products, as well as cosmetics, food and feed, and other consumer goods. She has assisted clients through the marketing authorization of medicinal products and related post-marketing activities. Hélène has gained a wealth of experience in relation to medical devices including the conformity assessment process for medical devices, and advising clients on the requirements introduced by the new medical devices regulations and various aspects of digital health technologies.
Hélène counsels clients on compliance with rules governing the promotion and advertising of healthcare products, interactions with healthcare professionals, as well as transparency and anti-benefits requirements. She also has experience in conducting due diligence and related counseling in connection with life sciences transactions.
Hélène advises clients on different aspects of the General Data Protection Regulation that are of particular importance in the life sciences sector, including the collection and processing of patients’ personal health data and the transfer of personal health data outside the EU.
As a Belgian-qualified lawyer, Hélène regularly advises international companies with complex queries in relation to Belgian law.
Prior to joining Sidley, Hélène worked as a trainee at the Food Task Force of the European Commission’s Directorate General for Competition and was an associate in the life sciences practice of another international law firm in Brussels.