Jeanne Fabre#5123

Jeanne Fabre

Jeanne is an associate at Allen & Overy and member of the firm's Life Sciences Regulatory practice.

Jeanne's practice mainly focuses on EU regulatory law in the Life Sciences sector, with a specific insight into French regulations. She assists and advises clients notably in the pharmaceutical, medical devices and cosmetics sectors, on a range of regulatory issues, such as clinical trials, marketing authorisations, advertising and promotion, pricing and reimbursement, CE marking and contracts.

Jeanne has also acquired first hand experience working as an in-house lawyer within pharmaceutical companies on a wide range of legal and regulatory topics (such as payment for performance, public tenders, confidentiality of prices, projects with patient associations) and on contractual matters (such as cross-border healthcare professionals, service providers, consultancy agreements and observational studies).
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

  • 2018

Membership

  • A&O Life Sciences Regulatory practice

Education

  • Paris-Est-Creteil University
  • Paris Descartes University

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