Graduated Plan Officer / QPPV
Under §63a AMG, the Graduated Plan Officer is responsible for managing the pharmacovigilance system, collecting and evaluating reports on drug risks, and coordinating any necessary measures to ensure patient safety. Similarly, other EU Member States require national pharmacovigilance representatives; Diapharm assumes this role for clients in the DACH and Benelux regions.
At the European level, this function is fulfilled by the Qualified Person for Pharmacovigilance (QPPV). The legal basis for this is Regulation (EC) No 724/2004 and Directive 2001/83/EC, as implemented into national law. Both the national QPPV and the EU-QPPV must have sufficient expertise and be available around the clock.
Taking Responsibility with Diapharm
Diapharm maintains its own robust pharmacovigilance system, enabling clients to meet European and national PV requirements without having to allocate additional internal resources or build their own PV infrastructure. Diapharm assumes the following functions:
- Qualified Person for Pharmacovigilance for the European Union (EU-QPPV)
- National QPPVs and local pharmacovigilance representatives for the DACH region and the Benelux Union
