Glossary of terms

Epidemiology is the study of factors affecting the health and illness of populations, and serves as the foundation and logic of interventions made in the interest of public health and preventive medicine.

European Medicines Agency - the European Union body responsible for coordinating the scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products.

European Risk Management Strategy (ERMS) - an initiative by the Heads of Medicines Agencies (HMA) started in July 2002 aiming at strengthening the safety-monitoring in the EU of medicinal products for human use by providing for a more coherent approach to the detection, assessment, minimisation and communication of risks of medicines in Europe. The rolling Two-Year Work Programme (2008-2009) to further progress the ERMS is available here: http://www.ema.europa.eu/pdfs/human/phv/28008907en.pdf.

Heads of Medicines Agencies (HMA) - a network of the Heads of the National Competent Authorities whose organisations are responsible for the regulation of Medicinal Products for human and veterinary use in the European Economic Area. The Heads of Medicines is supported by working groups covering specific areas of responsibility and by the Heads of Medicines Agencies Management Group and Permanent Secretariat. The Heads of Medicines Agencies co-operates with the European Medicines Agency and the European Commission in the operation of the European Medicines Regulatory Network.

Independent studies are understood as studies commissioned (for example by industry or regulatory authorities) to centres within ENCePP and which are performed according to best standard practice for pharmacoepidemiological research and according to rules and principles that ensure compliance with regulatory requirements and full transparency as laid down in the ENCePP Code of Conduct.

Marketing Authorisation (MA) is the approval to market a medicinal product in an EU Member State.

Network - a virtual structure defined by a formal agreement between individuals, organisations and/or structures sharing and collaborating towards the same objectives, goals and quality standards.

Pharmacoepidemiology, according to the International Society for Pharmacoepidemiology (ISPE), is the study of the utilisation and effects of drugs in large numbers of people. Thus, pharmacoepidemiology can be regarded as a bridging science spanning both pharmacology and epidemiology. It can also be defined as the application of epidemiological methods to pharmacological issues: pharmacoepidemiology benefits from the methodology developed in general epidemiology and may further develop epidemiological methods for applications of such methodology unique to pharmacoepidemiology. Pharmacoepidemiology is closely related to pharmacovigilance.

Pharmacology is the study of drug action. Pharmacology deals with how drugs interact within biological systems to affect function. It is the study of drugs, of the body's reaction to drugs, the sources of drugs, their nature, and their properties.

Pharmacovigilance can be defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other problem caused by the use of a medicine (in order to identify information about potential new hazards and to prevent harm to patients).

Post-authorisation safety studies (PASS) are pharmacoepidemiological studies or clinical trials carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying or quantifying a safety hazard relating to an authorised medicinal product (Article 1(15) of Directive 2001/83/EC).