Biomarkers are indicators used in medical research to measure biological processes, disease processes, and responses to treatment. The use of biomarkers can improve the process of medicines development and...
Information on medicinal products is provided to patients and healthcare providers in different, carefully regulated ways – including package labelling, package leaflets, and the Summary of Product Characteristics.
EudraVigilance is an EU web-based information system, designed to manage safety report data created by the European Medicines Agency (EMA) containing adverse reaction reports (ADRs) for medicines authorised in...
Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one...
Epidemiology is the study of the various factors influencing the occurrence, distribution, or prevention and control of disease, injury, and other health-related events in a defined human population.
Off-label use of a medicine is the use of an authorised medicine by a healthcare professional to treat a patient in a way not covered by the Marketing Authorisation...
The European Pharmacopoeia comprises quality standards for active pharmaceutical substances, as well as analytical methods for the identification of the substance and the evaluation of its quality and quantitative...
