Legal Guidance and Research / Experts / Maria Isabel Manley

Maria Isabel Manley

Maria Isabel ('Marie') Manley leads Sidley Austin's Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law. She represents development-stage and established global life sciences companies in a broad spectrum of matters, both contentious and non-contentious. Marie advises 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 IP, advertising, product liability and competition.

Marie has represented a number of the world's leading pharmaceutical 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 (NICE), and the Department of Health. She has extensive experience in coordinating multijurisdictional litigation throughout the EU/EEA and overseas.

Marie is recognized as a leader in her field, including a band 1 ranking in Chambers UK 2018 for Life Sciences: Regulatory, as well as recommendations in The Legal 500, Who's Who Legal and Best Lawyers. Most recently, she has been selected by her peers for inclusion in the Seventh Edition of The Best Lawyers in the United Kingdom (2019) for Life Sciences Law. Marie is also a lecturer at ESADE (Madrid).

Practice Area

Panels

  • Consulting Editorial Board
  • Contributing Author

Qualified Year

  • 1998

Membership

  • Chairperson of the Legal Affairs Community for the Drug Industry Association (DIA)
  • Association of British Healthcare Industries (ABHI)
  • Association of the British Pharmaceutical Industry (ABPI)
  • International Bar Association (IBA)
  • Legal Issues and Compliance Committee
  • ESADE Madrid

Education

  • Columbia University School of Law, LL.M., 1995
  • Universit de Lausanne, LL.M., 1992
  • Universit de Lausanne, LL.B., 1991
  • King's College London, Postgraduate Diploma in EU Competition Law, 2000

1 Contributions by Maria Isabel Manley

COVID-19 life sciences: UK and EU regulatory flexibilities on medicines, devices/PPE, clinical trials, inspections, supply, MDR delay, vaccines, R&D, funding and collaboration [Archived]
PRACTICE NOTES
COVID-19 life sciences: UK and EU regulatory flexibilities on medicines, devices/PPE, clinical trials, inspections, supply, MDR delay, vaccines, R&D, funding and collaboration [Archived]
ARCHIVED : This Practice Note has been archived and is not maintained. Coronavirus (COVID-19) poses an unparalleled test to the global life sciences sector. UK and EU regulators are issuing frequently updated guidance as the situation develops, and are supporting research and development aimed at limiting the spread’s impact. This Practice Note outlines how UK and EU authorities are responding in relation to: clinical trials and regulatory inspections maintaining continuity of supply for medicinal products and medical devices deferral of the application of Regulation (EU) 2017/745 (consolidated 24.04.2020), the Medical Devices Regulation (MDR) It also highlights major R&D initiatives across the UK and EU, and summarises European Commission guidance on collecting and transfusing convalescent COVID-19 plasma. For sector-specific developments and updates on coronavirus, see the Practice Notes: Coronavirus (COVID-19)—EU life sciences tracker [Archived] and Coronavirus (COVID-19)—UK life sciences tracker [Archived]. Medicinal products Regulatory framework adaptations The Commission, the European Medicines Agency (EMA) and the European medicines regulatory network have released a Q&A document, also endorsed by...
Life Sciences
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