EU Guidelines on Good Pharmacovigilance Practices (GVP Module IV), mandate that all Marketing Authorisation Holders (MAHs) perform audits of their Pharmacovigilance Systems.
PVpharm provides a risk-based Pharmacovigilance Audit Service, which focuses on the areas of highest risk to an organisation’s pharmacovigilance system, taking into account applicable local regulatory requirements.
With an average of +50 GVP audits per year in all geographical areas, PVpharm has a team of professionals that can conduct PV related audits in several areas, included but not limited to:
- Full PV systems audits
- Partner/Distributor PV audits
- Pre-qualification audits
- Patient Support Programs / Market Research Programs
- Local or country specific PV services
- Social Media
- Medical and Scientific literature monitoring
- XEVMPD
- Case management
- Signal detection
- PSURs