EMA Consults On Using Registry Studies As RWE Source
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.
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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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The European Commission has launched the process for reshaping and addressing the long-standing weakness in the EU’s pharmaceutical legislation. It has listed in a roadmap the issues it wants to address as it considers policy options for reforms.