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European Pharma Law Academy
Monday 2 - Friday 6 September 2024
Downing CollegeCambridge, UK

Marie Manley
Partner and Head of the Life Sciences Practice at Sidley
Speaker

Profile

Marie Manley leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law, with a career spanning more than 20 years.

Her clients range from development-stage to global life sciences companies, including pharmaceutical, medical device, borderline products and cosmetics. She advises on a broad spectrum of matters, both contentious and non-contentious, including bet-the-company regulatory matters, investigations and court challenges, with particular experience advising on issues arising during the life cycle of medicinal products, including IP regulatory rights, market access, advertising, product liability and competition. She is currently representing a leading pharma company before the English courts ( including the Supreme Court) in a landmark case (The Lawyer’s Top 20 Cases for 2021 and 2022; winning the 2022 LMG Life Sciences “Impact Case of the Year” and the 2022 Managing IP awards “UK Impact Case of the Year.”) et successfully represented pharma company before the EMA in relation to orphan drug status and paediatric issues (including paediatric extensions).

Marie has represented a number of the world’s leading pharmaceutical and life sciences companies in landmark cases 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 also lectured at ESADE Madrid on EU Pharmaceutical Law and the scope of IP regulatory rights. She is the co-author and co-editor of “Navigating European Pharmaceutical Law,” Oxford University Press, 2015

Marie is ranked as a Band 1 solicitor by Chambers UK 2019 and Chambers Europe 2019 for Life Sciences: Regulatory and she is also ranked as “Leading Individual” for Life Sciences and Healthcare by the Legal 500 UK 2023. Marie won the 2019 LMG “Women in Business Law Award” for “Best in Life Sciences” and more recently, Marie was recognized as “Lawyer of the Year” in Life Sciences Law by Best Lawyers 2021.

Agenda Sessions

  • Advanced SPCs

    10:00
  • Chair's Opening Remarks

    09:00
  • Chairperson’s Closing Remarks and End of Day 2

    17:20
  • Practical Workshop: Maximisation of IP Regulatory Rights

    16:00