Elisabethann has been practicing in the Life Sciences sector for over 30 years in both private practice and international institutions. She is among a handful of lawyers specialized in EU law and regulation of pharmaceuticals and medical devices who have consistently drawn praise from market sources for her knowledge of the legislation, technical competence, and commercial acumen. She helps clients 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, the establishment of a pathway to authorization 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. In recent years she has advised clients and published extensively on digital health issues, such as their implications for CE marking obligations for medical devices, and obligations for life sciences companies related to collecting and processing personal health data under the GDPR.