Regulatory Glossary
SUSAR
Suspected Unexpected Serious Adverse Reaction
Pharmacovigilance
Definition
A 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.
Related terms
GVP
The 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.
QPPV
The 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.
PSUR
The 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.
PMS
The 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.
Signal Detection
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.
Risk Management Plan
The 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.
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