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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.

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