The Product Management Service (PMS) is a core element of the European Medicines Agency's (EMA) IDMP implementation. PMS provides a centralized, standardized database for managing medicinal product information across the…
A branch of computer science dedicated to creating systems capable of performing tasks that typically require human intelligence. These tasks include learning, decision-making, problem-solving, and pattern recognition.
An observation is said to be censored in time when the event of interest cannot be observed at the time at which the analysis isconducted. Special cases are right censoring…
The evaluation of the likelihood that a medicine was the causative agent of an observed adverse event in a specific individual. Causality assessment is usually made according to established algorithms.…
A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.Source: ICH Guideline E6: Good Clinical…
A person who helps a patient with daily activities, healthcare, or other activities that the patient is unable to perform because of age, illness or disability, and who understands the…
A study that evaluates the association of specific genetic variants with outcomes or traits of interest, selecting the variants to be tested according to explicit considerations (known or postulated biology…
The additional load that a clinical activity imposes on patients above that which would be experienced under normal clinical practice. Source: (CIOMS XI: Patient involvement 2022)
A warning that appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks. Not all health authorities implement boxed warnings in the label,…
A correction to allow for the probability of many events that are independent, named after Carlo Emilio Bonferroni (1892-1960). In statistical significance testing, it allows, for example, 10 different significance…
A measured characteristic of either normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers.…
An analysis involving only two categories (e.g., baseline vs final values, in contrast to analysis of multiple values from continuous measurements, as for a progression of laboratory values). The latter…
Bayesian confidence propagation neural network (BCPNN) Empirical Bayesian algorithm used for signal detection in spontaneous report databases.Source: (CIOMS VIII: Signal detection 2010)
A theorem in probability named after Reverend Thomas Bayes (1702-1761). It is used to refer to a philosophy of statistics that treats probability statements as having degrees of belief, in…
Factors that describe study participants at the beginning of the study (e.g., age, sex, disease severity). In comparison studies, it is importantthat these characteristics be initially similar between groups; if…
A statistical method for making comparisons between groups, whiletaking into account different variables measured at the start of atrial. It is a form of multiple regression. Source: (CIOMS VI: Clinical…
An identified risk associated with the use of medicinal products which requires urgent measures to protect patients. Source: (CIOMS VIII: Signal detection 2010)
A tool that assesses the methodological rigour and transparency in which a guideline is developed. Source: (CIOMS XI: Patient involvement 2022)
One of 5 dimensions in the RE-AIM evaluation model (Reach, Efficacy, Adoption, Implementation, Maintenance). Adoption refers to the participation rate and representativeness of both the settings in which an intervention…
A risk minimisation measure which is in addition to the routine risk minimisation activities which apply to all medicinal products in a particular region or territory. Synonyms: Additional risk minimisation…
A system for the collection of case safety information as a continuous pre-organized process. Active surveillance can be: Drug based: identifying adverse events in patients taking certain products; Identifying adverse…
The degree of risk (likelihood of an adverse event or outcome) that a person or group is prepared to take or considers reasonable. However, what may be acceptable for one…
The environment or community concerned with research, education, and scholarship. Source: (CIOMS XI: Patient involvement 2022)
The number of people in a group who experience an adverse effect divided by the number in that group who could experience that adverse effect. Source: (CIOMS VI: Clinical trial…
A set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those activities and interventions.
The legal authority that is responsible for regulating all matters relating to drugs and medicinal products (e.g.: EMA, FDA, MHRA)
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 during the post-authorisation phase.
The date of the first marketing authorisation for any product containing the active substance granted to any company in any country in the world.
Comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed
Date of approval of the first authorization for conducting an interventional clinical trial in any country. Determines the start of regulatory requirement. The first data lock point for the DSUR…
Definition according to GVP Annex I (Rev 3): An identified risk or potential risk that could have an impact on the risk-benefit balance of the product or have implications for…
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 of interest but where this…
Definition according to GVP Annex I (Rev 3):An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest. Explanatory wording provided in GVP…
Temporal relationship is considered positive if the event occurred during the use of the drug and/or within a plausible range based on the half-life of the drug. Categories for temporal…
The term ‘severe’ must not be confused with ‘serious’. In the English language, ‘severe’ is used to describe the intensity (severity) of a specific event (mild, moderate or severe); the…
Persistent or sporadic, intentional excessive use of medicinal product, which is accompanied by harmful physical or psychological effects.
A SUSAR is a serious ADR whose nature or severity is unexpected based on the applicable product information.
An adverse reaction, the nature, severity or outcome of which is not consistent with the applicable product information. Any event that is not expected, in accordance with the label (USPI…
Unintended effect occurring at normal dose related to the pharmacological properties.
An international classification of drugs providing the names and active ingredient of medicinal products used in different countries.
Dictionary meant for rational coding of adverse reaction terms, maintained by the Uppsala Monitoring Centre (UMC), the World Health Organization Collaborating Centre for International Drug Monitoring.
It sets out the agreed usage of the drug in the USA and provides information for healthcare professionals on the drug’s usage, efficiency and safety. This is part if the…
An adverse reaction whose nature, severity, specificity, or outcome is not consistent with the description given in product labelling or market authorization (USPI in the US, SmPC in Europe).
A (augmented): common dose-related reaction, related to a pharmacological action of the drug, predictable and with low mortality.B (bizarre): uncommon non-dose-related reaction, not related to a pharmacological action of the…
Reporting of AE cases by health professionals and pharmaceutical companies which does not derive from a study or any organized data collection scheme (i.e. is not solicited). Stimulated reporting Reporting…
Reports derived from organized data collection systems, including: Clinical trialsClinical registriesPost-approval patient use programsPatient support programsPatient disease management programsSurveys of patients or healthcare providersInformation on efficacy or patient compliance
Evaluation of the data supporting a detected signal to verify that there is sufficient evidence demonstrating a new potentially causal association, or a new aspect of a known association.
A set of activities performed to determine whether there are signals associated with medicinal product (based on ICSRs, data from active surveillance systems or studies, literature information, etc.) including: Signal…
Reported information on a new possible causal relationship (or a new aspect of a known relationship) between an adverse event and a drug. A signal is considered important and warrants…
This part of an RMP provides a synopsis of a medicinal product’s safety. It should be a summary of: The important identified risksImportant potential risksMissing information It should also address:…
An important identified risk, important potential risk or important missing information. Medicinal product safety concerns are identified, characterized, and monitored in the DSUR, RMP and PSUR.
Evidence of an absence of harm (not absence of evidence of harm). Judgement about safety takes into account the degree to which a given risk is acceptable.
Non-profit consortium formed between the US FDA, industry, academia and the Wellcome Trust to identify genetic variants associated with SAEs.
results in deathrequires patient hospitalizationresults in persistent or significant disability or incapacityis life-threateningor is a congenital anomaly/birth defect.“Severe” describes the intensity of an event (mild, moderate or severe), the event…
Product informationHealthcare professional communications / educational materialsPatient communications / educational materials
MAHs must prepare an RMP (Risk Management Plan) to implement the risk management system.
Activity that aims to ensure that the benefits of a medicinal product exceed the risks by the greatest achievable margin, by increasing the benefits or reducing the risks in three…
The probability of developing an outcome (refers normally but not always to a negative outcome). Absolute risk or Incidence Rate: The observed or calculated probability of the occurrence of an event in a…
Risk in a population of unexposed persons. It can be measured over time (incidence) or at a given time (prevalence).
Therapeutic practice where drugs are prescribed and used appropriately for the indication and the patient’s specific characteristics.
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 from ADRs in humans arising…
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 risk management measures.
Administration of a quantity of a medicinal product above the maximum recommended dose allowed by the authorized product information.
Situations where a medicinal product is intentionally used for a medical purpose not in accordance with the marketing authorization. For instance, medicine used: For disease that it is not approved…
An Odds is the probability of an occurrence divided by the probability of its non-occurrence. The Odds ratio is the ratio of the Odds between two populations.
Number of individuals needed to be treated for some specified period in order that one person would have one harmful event.
Medication errors with high potential for causing harm but did not (cancelled before reaching a patient or reaching the patient but who did not have untoward consequences).
Regulatory authority within a country with the clinical and scientific expertise to collect, analyze and advise on drug safety.
Potentially clinically significant gap in knowledge about the safety of a medicinal product for a specific patient population or concerning certain anticipated utilization (for instance long term use). Typical examples…
An identifiable reporter, patient, event and a suspect medicinal product are required for reporting cases of suspected adverse events.
Any mistake in the way a medication is taken or administered (prescription, storage, dispensing, preparation, administration…), that has the potential to harm the patient. Medication errors are outside the use…
Any reaction not mentioned in the official approved product information is unlabeled (otherwise it is termed labelled).
The rate of new cases of an outcome occurring per number of known at risk or exposed; and is a measurement of risk.
MedDRA includes a term list of important medical events (available on the EMA website), which aims to facilitate the classification of suspected ADRs, data analysis and the assessment of ICSRs.
International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals.
The nature and extent of actual damage that can be caused by a drug. Damage is measured by frequency of occurrence, severity or duration.
The EMA has issued these guidelines for the conduct of pharmacovigilance in the EU for human medical products.
The following are standard ADR frequency categories where the denominator must be defined to provide context: Very common: > 10%Common: [1%, 10%]Uncommon: [0.1%, 1%]Rare: [0.01%, 0.1%]Very rare: <0.01%
Rapid submission of an ICSR to the Regulatory Authorities in compliance with the legislation and local regulatory guidelines.
ADR consistent with the reference safety information (Investigator’s brochure for an investigational product, summary of product characteristics) for an approved product.
The EMA’s system to support the electronic exchange, management, and evaluation of ICSRs related to all medicinal products authorized in the European Economic Area (EEA). Companies and Member States report…
European collaboration that established a collection of DNA samples for studying genes which influence SARs or ADRs, for the purpose of a better understanding of adverse drug reactions.
The ability of a drug to produce the intended effect (scientific evaluation).
Intentional off-label use of a medicinal product. Although the drug is not being used according to the marketing authorization or physician’s recommendation, abuse can result in ADRs.
Serious and rare medical event that is often causally associated with drugs across multiple pharmacological / therapeutic classes. Even small number of reports of such event can trigger a signal…
Screening of ICSR databases for statistical associations between products and events whereby the observed frequency is different than the expected frequency. For ADRs caused by one drug (called drug-event pairs),…
Plan to conduct the detection, assessment, understanding, reporting and prevention of AEs of medicinal products during clinical trials.