WP8 produced a document which provides recommendations on competency. This document aims to highlight the factors that could impact on the continuous professional development of NCAs’ assessors involved in Benefit Risk assessment of medicines, in order to support the quality, consistency and efficiency of the assessments process and to promote high-quality assessment standards and decision-making on regulatory measures. Moreover, the aim of the recommendations is to create the opportunity for work-sharing, linkage and cooperation among NCAs.
What does this document cover?
This recommendation document outlines some useful good practice examples concerning: processes and organisation, professional profiles requirements (Junior and Senior assessors), useful training courses and literature recommended by NCAs, such as some aspects relative to internal quality systems. Furthermore, this document provides the grounds and the basis for the future organisation of an exchange programme of EU pharmacovigilance assessors between NCAs.
The target audience is primarily pharmacovigilance assessors working at National Competent Authorities.
47 pages PDF.
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