Category: Glossary

Risk Management System (RMS)

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

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Regulatory Authority

The legal authority that is responsible for regulating all matters relating to drugs and medicinal products (e.g.: EMA, FDA, MHRA)

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Important Risk

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

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Potential Risk

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

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Identified Risk

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.

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Temporal Relationship

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

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Seriousness vs. Severity

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

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Abuse

Persistent or sporadic, intentional excessive use of medicinal product, which is accompanied by harmful physical or psychological effects.

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Unexpected Adverse Reaction

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

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Spontaneous Reporting

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

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Solicited Reports

Reports derived from organized data collection systems, including: Clinical trials Clinical registries Post-approval patient use programs Patient support programs Patient disease management programs Surveys of

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Signal Validation

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

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Signal Management Process

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,

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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

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Safety Specification

This part of an RMP provides a synopsis of a medicinal product’s safety. It should be a summary of: The important identified risks Important potential

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Safety Concern

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

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Safety

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.

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Risk Management

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

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Risk

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

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Rational Drug Use

Therapeutic practice where drugs are prescribed and used appropriately for the indication and the patient’s specific characteristics.

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Prevalence

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

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Pharmacovigilance System

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

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Pharmacovigilance Master File

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

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Pharmacovigilance

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

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Overdose

Administration of a quantity of a medicinal product above the maximum recommended dose allowed by the authorized product information.

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Off-Label Use or Misuse

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

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Odds and Odds Ratio

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

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Near-Misses

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

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Missing Information

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

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Medication Error

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

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Incidence

The rate of new cases of an outcome occurring per number of known at risk or exposed; and is a measurement of risk.

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Important Medical Event (IME)

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.

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ICH

International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals.

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Harm

The nature and extent of actual damage that can be caused by a drug. Damage is measured by frequency of occurrence, severity or duration.

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Frequency of ADRs

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:

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Expedited Reporting

Rapid submission of an ICSR to the Regulatory Authorities in compliance with the legislation and local regulatory guidelines.

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Expected Adverse Drug Reaction

ADR consistent with the reference safety information (Investigator’s brochure for an investigational product, summary of product characteristics) for an approved product.

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EudraVigilance

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).

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EUDRAGENE

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

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Drug Abuse

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

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Designated Medical Event (DME)

Serious and rare medical event that is often causally associated with drugs across multiple pharmacological / therapeutic classes. Even small number of reports of such

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Disproportionality Analysis

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

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Rechallenge

Rechallenge means reintroducing the drug to the patient. A positive rechallenge (the AE reappears) strongly suggests a causal relationship.

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Dechallenge

Dechallenge is the withdrawal of a drug from a patient to observe: The continuity of an AE (negative dechallenge – causal relationship less likely) The

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Data Monitoring Committee

Synonyms: Independent Data Monitoring Committee, Data and Safety Monitoring Board This committee is established by the sponsor to: Assess the progress of a clinical trial,

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Causal Relationship

The causal relationship between an AE and a suspected drug can be, according to the WHO: certain– sufficient information provided to determine that no other reasonable explanation exists,

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Critical Terms

“Critical Terms” in WHOART refer to or might indicate serious disease states and warrant special attention.

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Causality Assessment

Method for assigning probability to the likelihood of a causal relationship between an AE and a suspected drug; according to established algorithms.

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Case Reports

Individual reports of the experience of single patients, or patients managed as group. At minimum, an adverse event case report must have a reporter, product,

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Benefit-Risk Assessments

Analysis of the favorable (beneficial) and unfavorable results of doing specific actions. Also called “benefit-harm” or “effectiveness-risk” analysis

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Association

Events linked via one or multiple factors (i.e. chronology) but not necessarily having a cause and effect relationship.

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Aggregate reports

Reports of a set of cases, meant for regulatory authorities. Annual Safety Report (ASR): In clinical trials, an annual report of all newly available safety information.

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TMF Reference Model

A de facto industry standard that provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature.

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Subject

“1. An individual (either a healthy volunteer or a patient volunteer) whose reactions or responses to certain interventions are evaluated during a clinical trial. May

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Subinvestigator

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to

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Study Coordinator

Person who handles most of the administrative responsibilities of a clinical trial on behalf of a site investigator, acts as liaison between investigative site and

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