EMA Guidance On Registry-Based Studies Due This Month
The European Medicines Agency is planning an October workshop to discuss its new guideline on registry-based studies and to discuss recent experience on aspects such as the use of a large registry for clinical trials.
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A draft EU guideline explains how disease registries can be used to supplement evidence in the pre-authorization phase and provide infrastructure for post-authorization evidence generation.
Building on its ongoing patient registry initiative, the European Medicines Agency has issued recommendations on the methodological and operational aspects of the use of patient disease registries and registry studies for regulatory purposes.
The European Medicines Agency is looking at ways to make better use of existing patient registries - and help set-up new ones where needed - to generate additional data for the benefit-risk evaluation of medicines1. The project involves exploring, among other things, whether a registry can be used simultaneously to support both regulatory and health technology assessments.