Definition

The EU regulatory requirement for MAHs to have a designated qualified individual responsible for the establishment and maintenance of the pharmacovigilance system.

Example

The QPPV signs off on PSURs, is notified of urgent safety issues, and is ultimately responsible for regulatory compliance of the pharmacovigilance system.

Regulatory source

EU Directive 2001/83/EC, EU GVP Module I

Common mistakes

Treating QPPV as a purely administrative role. The QPPV must have sufficient authority and resources to fulfill their responsibilities.

Inspector question

Who is your QPPV? Demonstrate how they are notified of urgent safety issues and their involvement in key decisions.

Related terms