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Comments requested: Safety Evaluation Study Design
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7/21/2015 at 1:35:19 PM GMT
Posts: 4
Comments requested: Safety Evaluation Study Design

The members of the “Standardisation of post-registration surveillance” project group drafted a minimal data collection scheme starting from the analysis of the available registries/databases. It aims at collecting information on safety on patients using standard or new drugs in order to carry on a post marketing surveillance. This document contains questions related to the period of post-registration study and also to a second longer period of observation. The first part should last 100 ED using the inhibitor testing schedule currently required by EMA for all patients who start to use a new product. The second part is the collection of information of any adverse event, i.e. every 6 months for a longer period of time (1-3 years or for the entire life of patients). We would like to receive comments from scientific community.

Please see the attached documents and make comments on this post.

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