Helping companies around the world navigate the regulatory maze

EEA Qualified Person for Pharmacovigilance

Marketing Authorisation Holders (MAH) in the European Economic Area (EEA) must have permanently and continuously at their disposal a Qualified Person Responsible for Pharmacovigilance (QPPV). The QPPV is personally responsible for the establishment and maintenance of the MAH’s pharmacovigilance system.

Choosing to use a contract QPPV is an important decision. The relationship between a MAH and its QPPV needs to be one of trust, cooperation and flexibility. Mapi has a team of experienced QPPVs located in the UK with a proven track record of successful MAH-QPPV relationships in a wide variety of organisational systems. Our QPPVs have significant experience of regulatory inspections. Our QPPVs are:

  • Focused on patient safety;
  • Available 24 hours a day, 7 days a week;
  • Experienced pharmacovigilance personnel with good communication skills;
  • Up-to-date with legislation within the EEA and on a wider scale;
  • Pragmatic in their approach;
  • Adapt at pharmacovigilance system development;
  • Have access to a team of experienced safety physicians;
  • Experienced at overseeing all aspects of a pharmacovigilance system, including its Quality Management System;
  • Practiced at managing safety profiles of a wide diversity of products.

Request a consultation with an Strategic Regulatory Services expert