Eveline Van Keymeulen#2457

Eveline Van Keymeulen

Partner, Latham & Watkins
Eveline Van Keymeulen is a partner in Latham & Watkins’ Brussels and Paris offices and a member of the firm’s healthcare and life sciences practice.
 
Ms Van Keymeulen advises multinational companies and start-ups in the pharmaceutical, biotech, medical devices, cosmetics, and food and beverage sectors on a broad variety of complex European, domestic and cross-border regulatory matters, including clinical trials, product approvals, regulatory incentives, market access, promotion and advertising, post-market obligations, and general compliance matters.
 
In addition, Ms Van Keymeulen has extensive experience advising on medical cannabis and hemp-based product regulations. She successfully challenged the legality of French hemp regulations in the first case related to cannabidiol (CBD) products before the Court of Justice of the European Union (Case C-663/18, Kanavape). This landmark judgment had a major impact on the development of the European CBD industry. 
 
Ms Van Keymeulen is ranked in Chambers for Life Sciences Regulatory (since 2020) and recognised as a Legal 500 Rising Star / Next Generation Lawyer in Healthcare and Life Sciences (since 2018). She is considered a National and Global Leader by Who’s Who Legal Life Sciences (since 2016) and is further recognised as one of the leading life sciences practitioners in France by Legal Media Group 2021, Best Lawyers 2021 and Euromoney’s Women in Business Law Expert Guide 2021. Ms Van Keymeulen was also recognised as European Advisory Lawyer of the Year (2021) by, and won Impact Deal of the Year at, the prestigious Europe LMG Life Sciences Awards (2021-2022). Clients particularly value her “high level of energy”, and appreciate her for “being extremely flexible and genuinely engaged” as well as having a “can do attitude” while some have even called her a “rockstar”. 
 
Ms Van Keymeulen has authored numerous articles and has been a featured speaker on EU regulatory matters at prominent conferences such as the Pharmaceutical Law Academy in Cambridge. Ms Van Keymeulen also serves on the editorial board of the European Pharmaceutical Law Review. In addition, Ms Van Keymeulen has been quoted in BBC Business Daily, Bloomberg, The Times, Les Echos and other leading international business journals on life sciences regulatory and policy matters.
Contributed to

3

Pharmaceutical incentives in the EU
Pharmaceutical incentives in the EU
Practice notes

This Practice Note provides an overview of the EU protection mechanisms and incentives for medicinal products, known as pharmaceutical incentives. They include the supplementary protection certificates (SPCs), regulatory data protection and market protection, market exclusivity for orphan medicinal products and the incentives for paediatric medicines. This Practice Note also discusses how the pharmaceutical incentives interact in practice and the proposals for a review of their regime.

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).

The EU Clinical Trials Regulation
The EU Clinical Trials Regulation
Practice notes

This Practice Note looks at Regulation (EU) 536/2014, the EU Clinical Trials Regulation (CTR), which governs clinical trials in the EU. It discusses the key aspects of the CTR that clinical trial sponsors and pharmaceutical companies must be aware of.

Practice Area

Panel

  • Contributing Author

Qualified Year

  • 2007

Experience

  • Allen & Overy LLP (2013 - 2020)
  • Covington & Burling LLP (2008 - 2013)

Membership

  • EUCOPE – The European Confederation of Pharmaceutical Entrepreneurs
  • RAPS - Regulatory Affairs Professionals Society
  • DIA - Drug Information Association
  • Women@Life Sciences

Qualifications

  • Brussels Bar (2007)
  • New-York Bar (2010)
  • Paris Bar (2013)

Education

  • Master of Law (Intellectual Property), Université libre de Bruxelles, magna cum laude (2011)
  • LLM (Law & Technology), University of California, Berkeley, School of Law (2008)
  • Master in European Law, Ghent University School of Law, magna cum laude (2007)
  • Master of Law, Ghent University School of Law, magna cum laude (2006)

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