Definition

Qualified Person for Pharmacovigilance; responsible for the PV system in the EU (and similarly in other regions). Must be resident and contactable.

Example

QPPV named in MA dossier; available 24/7 for urgent safety issues.

Regulatory source

EU Directive 2001/83, GVP Module I

Common mistakes

QPPV not reachable or not adequately resourced.

Inspector question

Who is your QPPV and how is availability ensured?

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