Glossary of terms

ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) is a

Network established by the European Medicines Agency (EMA) as part of the European Risk Management Strategy to further enable proactive conduct of pharmacovigilance.

ENCePP Checklist for Study Protocols - a list of items to stimulate consideration of important principles when designing and writing a pharmacoepidemiological or pharmacovigilance study protocol. The Checklist is intended to promote the quality of such studies, not their uniformity. The Checklist is a supporting document and does not replace the format of the protocol for PASS as recommended in the Guidance and Module VIII of the Good pharmacovigilance practices (GVP).

ENCePP Code of Conduct - a set of rules and principles for pharmacoepidemiology and pharmacovigilance studies to promote transparency and scientific independence throughout the research process.

ENCePP Guide on Methodological Standards in Pharmacoepidemiology - an overview document and web resource providing methodological guidance for both experienced and new researchers in pharmacoepidemiology and pharmacovigilance.

ENCePP Resources Database - a publicly accessible electronic index of European research organisations, networks and data sources in the fields of pharmacoepidemiology and pharmacovigilance, available at the ENCePP web portal.

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.

EU PAS Register - the EU electronic register of post-authorisation studies maintained by the European Medicines Agency as cited in the Good pharmacovigilance practices (GVP).

European Medicines Agency (EMA) - the European Union body responsible for the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

European Risk Management Strategy (ERMS) - an initiative by the Heads of Medicines Agencies (HMA) which aims to provide for a more proactive conduct of pharmacovigilance by putting in place measures that allow for the early detection, assessment, minimisation and communication of risks of medicines in Europe throughout their lifecycle. More information on the ERMS is available here: European Risk Management Strategy (ERMS).

Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). The guideline on GVP is divided into 16 modules, each of which covers one major process in pharmacovigilance. More information is available here: Good pharmacovigilance practices.

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. More information is available here: Heads of Medicines Agencies

Independent studies - a study that is conducted - as far as possible - free from biases and commercial, financial and personal influences.

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.

New pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU) - was adopted by the European Parliament and European Council in December 2010 and has been effective since July 2012. The legislation is accompanied by the implementing regulation. This is a legally binding act published by the European Commission in June 2012 that provides details on the operational aspects for the new legislation: Commission implementing regulation No 520/2012 of 19 June 2012.

Non-interventional Study - defined in Dir 2001/20/EC Art 2(c) as a study where the following requirements are cumulatively fulfilled:

• the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorisation;

• the assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study; and

• no additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data.

Pharmacoepidemiology - defined as the study of the utilisation and effects of drugs in large numbers of people, borrowing from both pharmacology and epidemiology.

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 is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.

Post-authorisation safety study (PASS) is any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures (Article 1 (15) of Directive 2001/83/EC).

Primary Lead Investigator - if a study is conducted at several study sites by a team of investigators, the (primary) lead investigator is the investigator who has overall responsibility for the study across all sites.