Qualified Person for Pharmacovigilance – QPPV
A Qualified Person for Pharmacovigilance (QPPV) in accordance with Section 63a of the German Medicinal Products Act (AMG) is responsible for managing the pharmacovigilance system, collecting and evaluating reports on medicinal product risks, and, if necessary, coordinating measures to ensure patient safety. Similarly, other EU member states require national pharmacovigilance representatives; Diapharm assumes this function for the DACH and Benelux regions.
On a European level, this function is covered by the Qualified Person for Pharmacovigilance (EU-QPPV) under Regulation (EC) No 724/2004 and Directive 2001/83/EC. The national and EU-QPPV must have sufficient expertise and be available 24/7.
Pharmacovigilance Services by Diapharm
Diapharm operates a comprehensive pharmacovigilance system, enabling clients to meet European and national pharmacovigilance (PV) requirements without the need to establish additional capacity or set up their own PV system. Diapharm assumes the following functions:
- Qualified Person for Pharmacovigilance (EU-QPPV) for the European Union
- National QPPV, local pharmacovigilance representatives, for the DACH region and the Benelux Union
