Pharmacovigilance & drug safety

Pharmacovigilance is the science and detection of drug-related activities, as well as the assessment, comprehension, and prevention of adverse effects or any other drug-related problem. One of the main elements of adverse event reporting is the Individual Case Safety Report.  The triage step of a possible adverse event report is critical in determining whether the "four elements" of a valid ICSR are present, which are an identifiable patient, an identifiable reporter, a suspicious drug, and an adverse event. A variety of strategies are used for signal detection. SD is a crucial component of medication use and safety monitoring. A safety signal is defined by the WHO as "reported information on a causal relationship between an adverse event and a drug, the relationship previously unknown or incompletely documented." A risk management strategy is a recorded plan that discusses the hazards associated with the use of a drug and how they are managed.  The risks reported in an RMP are classified into three types: identifiable risks, possible risks, and unknown risks. Clinical trial reporting, also known as SAE (serious adverse event) reporting from clinical trials, safety information from clinical studies, is used to establish a drug's safety profile in humans and is a key component that drug regulatory authorities consider when deciding whether to grant or deny market authorization for a drug.

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