Eveline Van Keymeulen#2457

Eveline Van Keymeulen

Eveline is a Counsel at Allen & Overy and heads the firm's Life Sciences Regulatory practice. Eveline's practice focuses on EU Life Sciences regulatory law, and she has in-depth expertise in national regulations in France and Belgium. She advises multinational clients, in the pharmaceutical and medical devices sector, on a broad range of regulatory issues, including clinical trials, marketing authorisations and CE marking, advertising and promotion, product life cycle management, and pricing and reimbursement. Eveline is an active speaker and writer on Life Sciences topics, and serves as editor-in-chief of the A&O Life Sciences Hub, the A&O blog dedicated to Life Sciences. She is Associate Editor of the European Pharmaceutical Law Review and country correspondent for the Bio-Science Law Review. Eveline has been named as a "Next Generation Lawyer" by Legal 500 for Life Sciences (in 2018) and recognised by Who's Who Legal Life Sciences as one of the leading lawyers for Life Sciences: Regulatory (in 2016, 2017, and 2018). Clients say that Eveline is "excellent" and "very good and always a pleasure to work with." Eveline received her law degree from Ghent University and holds an LL.M. from the University of California, Berkeley, as well as a Master in European Law from Ghent University and a Master in Intellectual Property Law from Brussels University. She is admitted to the Brussels, Paris and New York bar.
Contributed to

1

Pharmacovigilance
Pharmacovigilance
Practice notes

This Practice Note deals with pharmacovigilance. It sets out the EU and UK regulatory framework and discusses the role of the Pharmacovigilance Risk Assessment Committee (PRAC), EudraVigilance and the guidelines on good pharmacovigilance practices (GVPs). It then takes a more detailed look at the pharmacovigilance processes and requirements set out in the GVP modules, including: how to establish a pharmacovigilance system, the qualified person responsible for pharmacovigilance (QPPV), the pharmacovigilance system master file (PSMF), pharmacovigilance inspections, pharmacovigilance audits, periodic safety update reports (PSURs), and post-authorisation safety studies (PASS). The Practice Note then considers non-compliance with pharmacovigilance requirements, data protection considerations, and outsourcing pharmacovigilance activities. Finally, it discusses pharmacovigilance in the UK and the role of the Medicines and Healthcare products Regulatory Agency (MHRA).

Practice Area

Panel

  • Contributing Author

Qualified Year

  • 2007

Membership

  • RAPS (Regulatory Affairs Professionals Society)
  • DIA (Drug Information Association)

Education

  • LL.M. in Law and Technology, University of California ' Berkeley, Boalt Hall School of Law, 2008
  • Master in European Law, Ghent University, 2007 ' magna cum laude
  • Master in Law, Ghent University, 2006 ' magna cum laude
  • Master in Intellectual Property Law, Brussels University, 2011 ' magna cum laude

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