Maria Isabel Manley#2867

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).
Contributed to

1

Coronavirus (COVID-19)—regulatory implications for the UK and European life sciences industry [Archived]
Coronavirus (COVID-19)—regulatory implications for the UK and European life sciences industry [Archived]
Practice notes

This Practice Note has been archived and is not maintained. It discusses the regulatory implications of the coronavirus (COVID-19) pandemic for the UK and European life sciences industry. It provides guidance as to the response of UK and EU regulators in the areas of clinical trials, inspections and the continuity of supply in medicinal products and medical devices, as well as the postponement of implementation of the Medical Devices Regulation (MDR). It also summarises key research and development (R&D) initiatives at a UK and EU level and European Commission guidance on the collection and transfusion of convalescent COVID-19 plasma.

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

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