Signal detection process is a set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, literature information or other data sources, there are new risks causally associated with an active substance or a medicinal product or whether known risks have changed.
A signal is the 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 verification action.
Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients.
Adverse Drug Reaction:
The detection, assessment, understanding and prevention of ADR are the objectives of the Pharmacovigilance.
ADR in the European Union:
An ADR is characterized as unintended and noxious responses to a drug and implies a possible causal relationship between the drug and the adverse event. ADR can happen during clinical trials or once the product is on the market.
ADR should be distinguished from untoward medical occurrence occurring after drug administration and where a causal relationship between the drug and the medical occurrence is excluded (called. Adverse Event).
Non-serious ADRs should be distinguished from the serious ones which can result in death, life-threatening, hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity or congenial anomaly / birth defect.