Month: October 2022

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

Read More »

Regulatory Authority

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

Read More »

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

Read More »

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

Read More »

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.

Read More »

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

Read More »

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

Read More »

Abuse

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

Read More »

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

Read More »

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

Read More »

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

Read More »

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

Read More »

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,

Read More »

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

Read More »

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

Read More »

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

Read More »

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.

Read More »

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

Read More »

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

Read More »

Rational Drug Use

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

Read More »

Prevalence

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

Read More »

Pharmacovigilance System

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

Read More »

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.

Read More »

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

Read More »

Overdose

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

Read More »

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

Read More »

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

Read More »

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

Read More »

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

Read More »

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

Read More »

Incidence

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

Read More »

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.

Read More »

ICH

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

Read More »

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.

Read More »

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:

Read More »

Expedited Reporting

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

Read More »

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.

Read More »

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).

Read More »

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

Read More »

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

Read More »

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

Read More »

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

Read More »

Rechallenge

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

Read More »

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

Read More »

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,

Read More »

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,

Read More »

Critical Terms

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

Read More »

Causality Assessment

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

Read More »

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,

Read More »

Benefit-Risk Assessments

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

Read More »

Association

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

Read More »

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.

Read More »