Description
The fundamental aim of drug safety assessment is to establish what adverse reactions may be caused by a medicinal product. Factors such as seriousness, severity, and frequency of reactions are then taken into account, along with the medical benefit of the drug, in establishing the benefit/risk profile of the product.
Product license holders and regulatory authorities monitor the safety of licensed drugs to detect adverse reactions that are unexpected qualitatively or quantitatively and that alter benefit/risk balance, and they take risk minimization action as necessary. Such pharmacovigilance principally involves the identification and evaluation of safety signals in information obtained from a wide range of data sources.
The methods used range from traditional medical assessment of individual spontaneous reports of adverse events, through ‘data mining’ of large databases, observational studies of ‘real world’ prescription and use, to interventional clinical trials.
This course provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four (4) stages: signal detection, signal validation, signal analysis and prioritization, and risk assessment and minimization.
This online course supplies the student with a guide that will help them understand signal detection and the proper management of approved products. The process for this subject matter is presented in four stages: minimization and risk assessment; prioritization and signal analysis; signal validation; and signal detection. Interventional clinical trials, observational studies of prescription, and their use in the real world, data mining through large databases, and traditional medical assessment of individual spontaneous reports of adverse events, are some of the methods used.
