WebOct 28, 2024 · Elsewhere in the guideline, EMA explains how marketing authorization holders and applicants can use the findings of registry-based studies. The acceptability of evidence from the studies depends on the product, the registry and the study, leading EMA to advise drug developers to consult with it or a national competent authority early. WebEMA guidelines specifically focus on data collected in disease registries, which is defined “as an organized system that collects data and information on a group of people defined by a particular disease or condition, and that serves a pre-determined scientific, clinical and/or public health (policy) purpose”.

EMA released today Final Guideline on Registry-based Studies

WebNov 7, 2024 · This guideline addresses the methodological, regulatory and operational aspects involved in using registry-based studies to support regulatory decision-making. … WebRegistry-based study “Investigation of a research question using the data collection infrastructure or patient population of one or several patient registries. A registry-based … melbourne weather in november

EMA - Guideline on registry-based studies Research Quality ...

WebSubmission of comments on ‘Guideline on registry-based studies’ (EMA/484811/2024) Comments from: Name of organisation or individual EFPIA – Ms Aneta Tyszkiewicz Please note that these comments and the identity of the sender will be published unless a specific justified objection is received. WebThe guidance defines registry-based studies as an investigation of a research question using the infrastructure of a new or existing patient registry, or from a registry newly set-up for the study. Registry-based studies as a source of RWE. In the draft guideline, the EMA focuses on registry-based studies as a tool to generate RWE. To ... narita weather accu