European Medicines Agency: Generating high-quality evidence from registry-based studies
29 ottobre 2021 – EMA has published guidance to provide key methods and good regulatory practices to pharmaceutical organisations on the planning and conduct of registry-based studies. The guideline aims to help those involved in registry-based studies to better define study populations and design study protocols; it provides further guidance on data collection, data quality management and data analysis to achieve higher quality evidence. This in turn will facilitate EU regulators’ assessment of the safety and effectiveness of medicines, for the benefit of public health.
For more information, see here.