Clinical Research and Clinical Trials 2020

Pharmacovigilance & Drug safety

Pharmacovigilance is the science and detection of relating activities, assessment, understanding and prevention of adverse effects or any other drug-related problem. Individual Case Safety Report is one of the fundamental principles of adverse event reporting.  The triage phase of a potential adverse event report, it has the great significance to determine the "four elements" of a valid ICSR are present they are -an identifiable patient, an identifiable reporter, a suspect drug, and an adverse event. Signal detection includes a range of techniques. SD is an essential part of drug use and safety supervision. The WHO defines a safety signal as: "Reported information on a causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously". A risk management plan is a documented plan that explains the risks occurred with the use of a drug and how they are being controlled.  The risks described in an RMP fall into one of three categories: identified risks, potential 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 in the decision-making as to whether to grant or deny market authorization for a drug.