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Practical Guide on PSUR/PSUSA Assessment

The purpose of this document is to provide practical guidance for National Competent Authority (NCA) assessors arising from WP8 – Lifecycle Pharmacovigilance, Benefit/Risk assessment in the context of Periodic Safety Update Report (PSUR) / Single assessment of Periodic Safety Update Reports (PSUSA) and Referral procedures.

What does this document cover?

1. Introduction

2. Practical guidance

 - Planning and organisation

 - Support for overcoming challenges during evaluation of risks/risk characterisation or for benefit/risk decision making

 - Different approaches to assessment according to the lifecycle of the medicine

 - Support for the drafting of questions to be addressed by the MAH

 - Support for better delivery of procedure recommendations and final outcomes

Target audience

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


18 pages PDF.

Click here to access this document. 

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