Revision to EMA Alzheimer’s Trial Guideline
The European Medicines Agency Guidelines on the clinical investigation of medicines for the treatment of Alzheimer's Disease (AD) were last updated in 2018. The Agency has recently published a concept paper concerning future revision of these Guidelines.
The revisions are, in part, the result of recent advances in the field of AD
Pilot system for sponsors of clinical investigations of medical devices
Sponsors of clinical investigations in the EU have been invited to apply to participate in a pilot scheme introducing a coordinated assessment of clinical investigations and performance studies as provided in Articles 78 of the Medical device Regulation and Article 74 of the in vitro diagnostic medical devices Regulation (https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en).