Elisabethann Wright specializes in EU law and regulation of pharmaceuticals and medical devices and is regularly sought-after and praised for her knowledge of the legislation, technical competence and commercial acumen. She has been practicing in the life sciences sector for over 35 years in private practice and international institutions. Elisabethann helps clients navigate the process and regulations to place and keep their products on the European Union market through strategic advice, advocacy before institutions and agencies and litigation before EU courts.
Her experience covers the full regulatory life cycle of products: classification of their products, establishment of a pathway to authorization, or CE marking and marketing of their products in the EU (including related regulatory obligations), pharmacovigilance obligations, conformity assessment of medical devices, promotion and marketing of products, sales agreements, clinical trial agreements, adverse event reporting, product withdrawals, data privacy obligations, and conduct of compliance and anti-bribery investigations.
Elisabethann advises clients and publishes extensively on digital health issues, such as their implications for CE marking obligations for medical devices, and related obligations for life sciences companies.
She has substantial experience in litigation before the European Court of Justice, the General Court of the European Union and the European Free Trade Agreement (EFTA) Court, including challenges, on behalf of industry clients, to decisions of EU institutions and the validity of EU legislation. Elisabethann was a Référendaire (Law Clerk) at the Court of Justice of the European Communities for several years.
Elisabethann is recognized as a leading practitioner in the field by Chambers Europe, Legal 500, Best Lawyers in Belgium, Who’s Who Legal and Acritas Stars.