Pharmacovigilance Terms (16)

Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a pharmaceutical product, recorded whether or not it is considered drug related; causality is assessed separately, not presumed.

Black Box Warning is FDA's most serious prescription drug labeling warning, a bordered box at the start of the prescribing information reserved for contraindications or serious warnings that may lead to death or serious injury.

DSUR is the annual clinical-trial safety report a sponsor submits to regulators for an investigational drug, consolidating all trials of that drug worldwide, unlike the PSUR, which covers products already on the market.

Medical Dictionary for Regulatory Activities (MedDRA) is the standardized medical terminology ICH regions use to code adverse events, indications, and medical history in safety reports, structured as a five-level hierarchy from Lowest Level Term up to System Organ Class.

MedWatch is FDA's safety reporting program and form set for human medical products, covering both voluntary reports from clinicians and patients and the mandatory postmarket reports sponsors and manufacturers must file under 21 CFR.

The Periodic Benefit-Risk Evaluation Report (PBRER) is the ICH E2C(R2) periodic safety report for marketed medicines, distinguished from the earlier PSUR format by a formal evaluation of benefit alongside risk to support an explicit benefit-risk conclusion.

Periodic Safety Update Report is a pharmacovigilance document a marketing authorisation holder submits at fixed intervals to re-evaluate an authorised medicine's benefit-risk balance against the safety data accumulated worldwide since the previous report.

Pharmacovigilance is the regulated safety discipline covering detection, assessment, understanding, and prevention of adverse drug reactions, and the reporting obligations that bind sponsors during trials and marketing authorisation holders for as long as a product stays on the market.

Pharmacovigilance System Master File (PSMF) is the detailed description of the pharmacovigilance system a marketing authorisation holder operates for EU-authorised medicines, kept at one registered EU site and produced to competent authorities within seven days of request.

Qualified Person for Pharmacovigilance (QPPV) is the single named individual, resident in the EU/EEA, whom a marketing authorisation holder must have permanently and continuously at its disposal to establish and maintain its EU pharmacovigilance system.

Risk Evaluation and Mitigation Strategy (REMS) is an FDA-mandated drug safety program that imposes enforceable conditions on prescribing, dispensing, or patient monitoring whenever FDA determines those conditions are necessary to ensure a drug's benefits outweigh its risks.

RMP is the EU regulatory document that records a medicinal product's risk management system: the important identified risks, important potential risks, and missing information, plus the pharmacovigilance and risk-minimisation activities that address them.

An SAE is any adverse event or suspected adverse reaction that results in death, a life-threatening event, inpatient hospitalization or its prolongation, persistent or significant incapacity, or a congenital anomaly, in the view of either the investigator or sponsor.

Signal detection is the pharmacovigilance activity of searching safety data for evidence that a medicine may cause a new adverse reaction, or that a known reaction has changed, before that evidence is confirmed.

Signal management is the pharmacovigilance process that carries a suspected safety issue from detection through validation, confirmation, prioritisation and assessment to a documented regulatory decision, with every step, date and rationale tracked.

SUSAR is a serious adverse reaction observed in a clinical trial that is both suspected to be caused by the investigational drug and not already described in the current investigator brochure, triggering expedited regulatory reporting.