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Practical Guide on PASS Assessment

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?

Introduction

Practical guidance

Practical approach

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

Target audience

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

Duration

15 pages PDF.

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