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Practical Guide on Risk Management Plan Assessment

The purpose of this document is to provide a practical guidance on the Risk Management Plan (RMP) assessment and on drafting of assessment reports. The SCOPE survey, based on a questionnaire to National Competent Authorities (NCAs) concerning their experience and practice in assessing RMPs, is the main source for the practical guide given in this document.

What does this document cover?

1. Introduction

2. Practical guidance

 - Practical approach

 - Support for overcoming challenges during evaluation of different parts of the RMP

 - Support for drafting requests for supplementary information

 - Support for better delivery of procedure recommendations and final outcomes

 - Updates of RMP

Target audience

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


16 pages PDF.

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