Pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorisation holders at defined time points

Definition according to GVP Annex I (Rev 3):An untoward occurrence for which there is some basis for suspicion of an association with the medicinal product

The proportion of total cases in a population at a particular time and a descriptive statistic, rather than a measurement of risk.

System created to monitor adverse drug events for identified patients receiving a specified drug (prescribers are requested to report all events, suspected adverse or not).

Aspects of the patient’s history which might explain reported adverse events (genetic, other drugs, disease history…).

The study of drug use and effects after release into the market.

A system used by an organization to comply with pharmacovigilance regulations and designed to monitor the safety of authorized medicinal products.

A compilation of information, maintained by the MAH. containing a detailed description of the pharmacovigilance system they use, available to competent authorities upon request.

The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, in order to: Prevent harm

Study of the uses, effects and modes of action of drugs.

The study of the use and effects of drugs in large numbers of people using an epidemiological approach

Study relating to an authorized medicinal product conducted with the aim of studying a safety hazard, confirming the safety profile of the product, or evaluating

Any change, divergence, or departure from the study design or procedures defined in the protocol Source: ICH

A written description of a change(s) to or formal clarification of a protocol. Source: ICH E6

The written description of a clinical study. It includes the study’s objectives, design, and methods. It may also include relevant scientific background and statistical information.

The person who is responsible for the scientific and technical direction of the clinical trial at a specific clinical site. In most cases the principal

An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.

A clinical study designed & executed to get statistically significant evidence of efficacy and safety in order to obtain its marketing approval by regulatory authorities.

A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that

A phase of research to describe clinical trials that gather more information about a drug’s safety and effectiveness by studying different populations and different dosages

A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that

A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the

A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body.

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The

The processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine. Source: NLM

A type of observational study that collects information about patients’ medical conditions and/or treatments to better understand how a condition or treatment affects patients in

An outcome based on a report that comes directly from the patient about the status of a patient’s health condition without amendment or interpretation of

[FDA] Designation given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists, where the time it takes

United States governmental initiative to address the global HIV/AIDS epidemic and help save the lives of those suffering from the disease.

[FDA] A previously published set of rules with the exception of part 11 (such as GLPs, GCP, or cGMPs) that mandate what records must be

The plasma master file (PMF) is a compilation of all the required scientific data on the quality and safety of human plasma relevant to the

[EMA] The European Medicines Agency’s (EMA) committee responsible for assessing and monitoring the safety of human medicines. Source: Pharmacovigilance Risk Assessment Committee (PRAC)

A pharmacopoeia is a book describing drugs, chemicals, and medicinal preparations which is issued by an officially recognized authority and serves as a standard.

The Pharmaceuticals and Medical Devices Agency is an Independent Administrative Institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in

[FDA] Patient labeling that is part of the FDA-approved prescription drug labeling. PPIs are developed by the manufacturer, approved by the FDA, and are required

[SPOR] Uniquely identifies a Medicinal Product based on its packaging. This implies one MPID can be associated with more than one PCID, if the same