Hi All,
In this Article, we will see What is Signal in Pharmacovigilance?
Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action.
New aspects of a known association may include changes in the frequency, distribution (e.g. gender, age and country), duration, severity or outcome of the adverse reaction.
For the purpose of monitoring data in the EudraVigilance database, only signals related to an adverse reaction shall be considered.
For the purpose of Section 16.2 of the periodic benefit-risk evaluation report, signals relate to adverse effects.
Signals are continuously monitored and evaluated by the company.
New signal which emerge, remain ongoing, or are closed during the reporting period are presented in the PSUR/PBRER
Closed signal
A safety signal can be closed either because it is refuted or because it is determined to be a potential or identified risk following evaluation
Ongoing signal
In periodic benefit-risk evaluation reports, a signal that remains under evaluation at the data lock point.
Newly identified signal
In periodic benefit-risk evaluation reports, a signal first identified during the reporting interval, prompting further actions or evaluation.
Confirmed signal
For the signal management process in the EU, a validated signal entered in the European Pharmacovigilance Issues Tracking Tool (EPITT) that requires further analysis and prioritisation by the Pharmacovigilance Risk Assessment Committee (PRAC), according to the PRAC Rapporteur or (lead) Member State.
Non-confirmed signal
For the signal management process in the EU, a validated signal entered in the European Pharmacovigilance Issues Tracking Tool (EPITT) that does not require further analysis and prioritisation by the Pharmacovigilance Risk Assessment Committee (PRAC) at that point in time, according to the PRAC Rapporteur or (lead) Member State.
Validated signal
A signal for which the signal validation process has verified that the available documentation contains sufficient evidence demonstrating the existence of a new potentially causal association, or a new aspect of a known association, and therefore justifies further analysis of the signal.
Non-validated signal
A signal for which the signal validation process has led to the conclusion that the available documentation at that point in time does not contain sufficient evidence demonstrating the existence of a new potentially causal association, or a new aspect of a known association, and that therefore further analysis of the signal is not warranted.
Refuted signal
A validated signal which, following further assessment has been determined to be “false”, i.e. a causal association cannot be established at that point in time.
It is noted that for the purpose of the periodic benefit-risk evaluation report (PBRER) ICH describes refuted signals as signals that, following evaluation, have been refuted as “false” signals based on medical judgment and a scientific evaluation of the currently available information.
Emerging safety issue (ESI)
A safety issue considered by a marketing authorisation holder to require urgent attention by the competent authority because of the potential major impact on the risk-benefit balance of the medicinal product and/or on patients’ or public health and the potential need for prompt regulatory action and communication to patients and healthcare professionals.
Examples of ESI:
- Major safety issues identified in the context of ongoing or newly completed studies, e.g. an unexpectedly increased rate of fatal or life-threatening adverse events;
- Major safety issues identified through the spontaneous reporting system or publications in the scientific literature, which may lead to considering a contraindication, a restriction of use of a medicinal product or its withdrawal from the market;
- Major safety-related regulatory actions outside the EU, e.g. a restriction of use of a medicinal product or its suspension.