Maria Isabel Manley
UK Guide 2024
Band 1 : Life Sciences: Regulatory
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Band 1
About
Provided by Maria Isabel Manley
Practice Areas
MARIA ISABEL MANLEY leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law. She represents development-stage, specialty and established global life sciences companies in a broad spectrum of matters, both contentious and non-contentious, including bet-the-company regulatory matters, investigations and court challenges. Marie advises and successfully represents clients in the pharmaceutical, biotechnology, medical devices, chemicals, cosmetics and food sectors in proceedings before both national and European courts and the regulatory agencies in the UK and across Europe. She has particular experience on issues arising during the life cycle of medicinal products, including optimization of IP regulatory rights, advertising, product liability, competition and market access issues (including representing and advising clients in their interaction with NICE and NHS England). Marie also has experience in advising life sciences companies in commercializing e-health and m-health products in the EU, including advising on their compliance with the EU legal framework and market access issues. Marie has successfully represented a number of the world’s leading pharmaceutical and life sciences companies in litigation before the EU and English Courts, as well as before the regulatory authorities, including the European Commission, the European and UK medicines authorities (EMA and MHRA), the National Institute for Health and Clinical Excellence and the Department of Health. She has extensive experience in coordinating multi-jurisdictional litigation throughout the EU/EEA and overseas. Marie recently represented a pharmaceutical company in high-value, follow-on damages proceedings in the UK concerning the intersection between competition, regulatory and patent law and recently acted in two appeals before the UK Supreme Court and a month-long trial before the High Court, winning the 2022 LMG Life Sciences “Impact Case of the Year” and the 2022 Managing IP awards “UK Impact Case of the Year.”
Professional Memberships
Marie is Chairperson of the Legal Affairs Community for the Drug Industry Association and a member of the Association of British HealthTech Industries and the Association of British Pharmaceutical Industry.
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