Term of the Day
Natural History Study
A natural history study is a preplanned intended to track the course of the disease. Its purpose is to identify demographic, genetic, environmental, and other variables (e.g., treatment modalities, concomitant medications) that correlate with the disease’s development and outcomes. Natural history studies are likely to include patients receiving the current standard of care and/or emergent care, which may alter some manifestations of the disease.
European Medicines Agency (EMA)
The European Medicines Agency (EMA) is an european institution which mission is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union (EU). The Agency uses a wide range of regulatory mechanisms to enable timely patient access to new medicines and supports medicine development. It also monitors and mitigates potential or actual shortages of critical medicines caused by major events and in crisis situations.