The purpose of this document is to provide practical guidance from WP8 Lifecycle Pharmacovigilance, Post-Authorisation Safety Studies (PASS) assessment. The practical guide covers assessment of both PASS protocols and study reports. This document is intended to give practical guidance on some aspects of PASS assessment and drafting of Assessment Reports.
What does this document cover?
Support for overcoming challenges during evaluation of PASS protocol and results
Support for drafting requests for supplementary information
Annex 1. Guidelines checklists, registries and databases
Annex 2. The AEMPS Guide
The target audience is primarily pharmacovigilance assessors working at National Competent Authorities.
15 pages PDF.
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