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Identification of Available Data Sources Outside Spontaneous Report: Recommendations

This document aims to provide recommendations emerging from Work Package (WP) 8 – Lifecycle pharmacovigilance, Identification of available data sources outside of spontaneous reports. The recommendations include the main findings, principal conclusions and List of Alternative Data Sources (ADSs) useful for pharmacovigilance (PV) assessments. The document is intended to offer support to European Union (EU) assessors in identifying suitable data sources, accessible to National Competent Authorities (NCAs), for a better characterisation and understanding of the profile of a medicinal product during a PV procedure. Furthermore, these data sources could be useful in the evaluation of the impact of regulatory measures, in accordance with the current legislation.

What does this document cover?

1. Introduction

2. Recommendations:

 - The list of useful ADSs

 - Exchange of information concerning experiences/good practices in use of ADSs               

 - Better addressing of possible challenges for ADS information availability

 - Mapping of ADSs

 - Grouping of ADSs on the type of safety issue basis

 - New strategies for the promotion of innovative methodologies and technologies

 - Linkage between different European initiatives

Annexes - WP8 Topic 1 Survey Report, examples of good experience in Spain, Italy, and the United Kingdom.

Target audience

The target audience is primarily pharmacovigilance assessors working at National Competent Authorities.


20 pages PDF.

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