Blog Post
European Commission provides clarification regarding the implementation of the Clinical Trials Regulation
18 November 2019
PartnerBrussels
Email ea.wright@hoganlovells.com
Phone +32 2 505 09 11
Fax +32 2 505 0996
LanguagesEnglish, Dutch, French
Practice groupGlobal Regulatory
Listed as an expert in regulatory issues on EU Life Sciences law.
Who's Who Legal: Life Sciences 2017
Elisabethann has been practising 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, establishment of a pathway to authorisation 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.
Elisabethann has substantial experience in litigation before the European Court of Justice, the European Court of First Instance, 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.
Biotechnology and Life Sciences Practice
Best Lawyers in Belgium
Acritas Star
Acritas Stars Independently Rated Lawyers
EU Regulatory: Pharma, Medical Devices and Biotech, Leading Individual
Legal 500 EMEA
EU Regulatory: Food
Legal 500 EMEA
Elisabethann Wright is ranked Band 1 by Chambers Belgium 2017 for Life Sciences and Band 2 by Chambers Europe 2017 for Life Sciences
Listed as expert in regulatory issues on EU Life Sciences law
Who's Who Legal: Life Sciences 2017
Brussels Life Sciences practices awarded Finance Monthly – Law Award 2015 in the category of Life Sciences Law Firm of the Year – Belgium
Listed as 'leading authority' on EU Life Sciences law
Who's Who Legal: Life Sciences
Recognised as one of the five "most highly regarded individuals" worldwide
Who's Who Legal: Life Sciences 2014 edition
Brussels office's Life Sciences Practice is ranked in Tier 1 by Legal 500 and Chambers 2014
Pharmaceuticals and biotechnology - Belgium
Legal 500, EU Regulatory
Regulatory
PLC Life Sciences Cross-border Handbook
Education
Postgraduate Diploma in EC Competition Law, King's College London, 2004
B.L., The Institute of Professional Legal Studies, Belfast, 1985
LL.B., The Queen's University of Belfast, 1984
Bar admissions and qualifications
Brussels
Barrister, Republic of Ireland
Barrister, England and Wales
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