Pharmacoepidemiology is being used increasingly to evaluate health care systems, interventions, and health-related behaviors. Pharmacoepidemiology is the scientific backbone of therapeutic risk management—the process of assessing a product’s benefits and

Postmarketing surveillance is the monitoring of drug performance in clinical practice and the taking of appropriate action to improve patient safety. The action taken can range from changes in product

The role of pharmacovigilance is to determine which adverse events cross the line of a drug’s efficacy. In other words, analysing which side effects are worth the risk to patients

The Uppsala Monitoring Centre (UMC) offers medical terminologies and analytical services for the international community of pharma, biotech and CRO companies, academia and software developers. If clinical trials or drug

Pharmacovigilance legislation was developed in a bid to significantly reduce the number of adverse drug reactions, which were found to be causing nearly 200,000 deaths per year in the EU. Many of

An adverse drug reaction (ADR) can be defined as ‘an appreciably harmful or unpleasant reaction resulting from an intervention related to the use of a medicinal product; adverse effects usually

The U.S. Food and Drug Administration (FDA) defines an adverse drug experience as any AE associated with the use of a drug in humans, whether or not considered drug related,