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Practical Guide on Safety-related Referrals

This guide may be useful for any Assessor who is involved in a safety-related referral. It offers practical advice at all stages of the process and should be used in conjunction with other relevant guidance and the EMA templates. It is mostly written from the perspective of the (Co)-rapporteur Assessor, but many aspects may also be of value to the non-rapporteur. This guide is not intended to provide procedural, scientific or benefit/risk (B/R) evaluation guidance.

What does this document cover?

1. Introduction

2. Practical guidance

 - Planning and organisation

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

 - Support for drafting the list of outstanding issues

 - Support for better delivery of high quality recommendations and final outcomes

Target audience

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


22 pages PDF.

Click here to access this document. 

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