---
title: "Signal Detection — Definition | QbD Group"
description: "The activity of identifying new or changed safety information from spontaneous reports, literature, studies, and other sources, then validating and prio..."
url: https://qbdgroup.com/en/knowledge-center/glossary/signal-detection
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"Signal Detection — Definition | QbD Group\", https://qbdgroup.com/en/knowledge-center/glossary/signal-detection"
---

[Back to the glossary](https://qbdgroup.com/en/knowledge-center/glossary) Regulatory Glossary

# Signal Detection

Pharmacovigilance

## Definition

The activity of identifying new or changed safety information from spontaneous reports, literature, studies, and other sources, then validating and prioritising it to decide whether the product's risk profile or labelling needs to change.

## Related terms

[GVPThe EMA modules setting out how marketing authorisation holders and authorities must run pharmacovigilance: quality systems, the pharmacovigilance system master file, risk management, signal management, safety reporting, and post-authorisation safety studies.](https://qbdgroup.com/en/knowledge-center/glossary/gvp)[QPPVThe individual a marketing authorisation holder must appoint in the EU to establish and maintain the pharmacovigilance system. The QPPV has oversight of the safety profile of all authorised products and is the authorities' round-the-clock point of contact.](https://qbdgroup.com/en/knowledge-center/glossary/qppv)[PSURThe periodic report in which a marketing authorisation holder re-evaluates the benefit-risk balance of an authorised medicine using cumulative safety data, exposure estimates, and signal evaluations over the reporting interval.](https://qbdgroup.com/en/knowledge-center/glossary/psur)[PMSThe systematic collection and review of experience gained from devices or medicines already on the market, feeding complaint handling, vigilance reporting, risk management, and the periodic safety update report or PSUR equivalent for devices.](https://qbdgroup.com/en/knowledge-center/glossary/pms)[SUSARA serious adverse reaction in a clinical trial that is suspected to relate to the investigational product and whose nature or severity is not consistent with the reference safety information. SUSARs are subject to expedited reporting to authorities and ethics committees.](https://qbdgroup.com/en/knowledge-center/glossary/susar)[Risk Management PlanThe document describing what is known and unknown about a medicine's safety, the measures planned to characterise and minimise its risks, and how the effectiveness of those measures will be measured over the product's lifecycle.](https://qbdgroup.com/en/knowledge-center/glossary/risk-management-plan)

## Need more than a definition?

Our regulatory, quality, and clinical specialists turn these requirements into working submissions, systems, and studies.

[Explore our services](https://qbdgroup.com/en/services)[Talk to an expert](https://qbdgroup.com/en/contact)

---

Source: https://qbdgroup.com/en/knowledge-center/glossary/signal-detection — © QbD Group. Quote freely with attribution and a link back.