EMA: Qualification opinion of low hippocampal volume (atrophy) by MRI for use in clinical trials for regulatory purpose - in pre-dementia stage of Alzheimer’s disease

The European Medicines Agency’s (EMA) qualification process is a new, voluntary, scientific pathway leading to either a CHMP opinion or a Scientific Advice of novel methodologies on innovative methods or drug development tools. It includes qualification of biomarkers developed by consortia, networks, public/private partnerships, learned societies or pharmaceutical industry for a specific intended use in pharmaceutical research and development.