Pharmacovigilance
Pharmacovigilance is defined as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems." This definition encompasses the use of pharmacoepidemiological studies. Pharmacovigilance principally involves the identification and evaluation of safety signals.
Safety signal refers to a concern about an excess of adverse events compared to what would be expected to be associated with a product's use.
Signals can arise from postmarketing data and other sources, such as preclinical data and events associated with other products in the same pharmacologic class. It is possible that even a single well-documented case report can be viewed as a signal, particularly if the report describes a positive rechallenge or if the event is extremely rare in the absence of drug use.
Signals generally indicate the need for further investigation, which may or may not lead to the conclusion that the product caused the event. After a signal is identified, it should be further assessed to determine whether it represents a potential safety risk and whether other action should be taken.
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Summary of regulatory requirements for product safety reporting - types of metrics used - implementing metrics successfully
Pharmacovigilance systems - Reporting and Management of Adverse Reactions - Periodic Safety Update Reports - Post Authorization Safety Studies
Regulatory expectations for reporting in multi-company development and marketing programs - International standards for data exchange - Practical aspects of compliance with standards and regulations
