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Quality Standards of Pharmacovigilance Assessment

This document aims to provide practical guidance for Pharmacovigilance (PV) assessors arising from the work in Work Package 7 – Quality Management Systems, and understanding of national quality systems in the context of the quality of assessment reports.

This document was written to offer some practical guidance on key aspects regarding the quality control of assessment reports. It is acknowledged that there are different structures in place for pharmacovigilance assessment across the member states (MSs). However, the focus of this paper is on the actual assessment reports and not the workflow of the PV procedures. This document can be applied horizontally to all PV procedures whenever it is necessary to write an assessment report, independent of the nature of the assessment process, quality of data submission, therapeutic area or the safety issues under review. Ultimately, this tool may also be important in underlining and assessing the needs of each assessor in terms of relevant additional training.

What does this document cover?

1. Introduction

2. Establishing Quality Standards for PV Assessment

Annex – Guidance Checklist for Pharmacovigilance Assessors

Target audience

The target audience is primarily pharmacovigilance staff working at EU NCAs.


10 pages PDF.

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