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PASS Recommendations

This document aims to provide recommendations arising from Work Package 8 (WP8) Lifecycle Pharmacovigilance (PV), Topic 3 Post Authorisation Safety Studies (PASS) assessment. The recommendations cover both assessment of protocols and study reports.

What does this document cover?

1. Introduction

2. Recommendations:

 - Organisation and process

 - Epidemiologic support function

 - Training policy

 - Training material recommendation

Annex – WP8 Practical Guide on PASS Assessment

Target audience

Assessors at National Competent Authorities are the primary target group for these recommendations, but also the lead of assessor teams and administrative leads within the pharmacovigilance area at NCAs are within the target groups.


13 pages PDF.

Click here to access this document. 

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