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LOG FORM: EU-QPPV Absence and Deputy Coverage Record

LOG FORM: EU-QPPV Absence and Deputy Coverage Record

189,00€Preis
exkl. MwSt.

This log form template documents the planned absence of the EU Qualified Person for Pharmacovigilance (EU-QPPV) and the delegation of responsibilities to the designated Deputy QPPV (dQPPV) to ensure continuous pharmacovigilance oversight.

 

The template supports proper documentation of the handover process before, during, and after the absence of the EU-QPPV. It helps ensure that critical pharmacovigilance activities and safety information are reviewed and transferred appropriately between the EU-QPPV and the deputy.

 

The form includes sections for:

  • EU-QPPV absence period

  • Overview of ongoing pharmacovigilance activities

  • Escalation pathways for critical safety issues

  • Summary of PV activities during the absence period

  • Post-absence handover and confirmation

 

This log form supports clear documentation of EU-QPPV availability arrangements and can be used together with procedures describing EU-QPPV responsibilities and back-up coverage.

 

 

Typical use cases

  • Documenting EU-QPPV absence and deputy coverage

  • Supporting EU GVP pharmacovigilance governance

  • Preparing for pharmacovigilance inspections

  • Maintaining documented PV oversight and accountability

 

Document format

Editable template provided in Word format, allowing easy customization to fit the company’s pharmacovigilance procedures.

  • If you prefer expert guidance, OZQA provide PV Services, such as:

    • Establishment of full PV system, including PSMF and PV SOPs
    • Gap analysis of existing PV system
    • PV audits
    • QPPV support, including management of PV Agreements, PV intelligence, PV SOPs, PV training and PV compliance
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