Once a safety signal is detected, a series of steps are undertaken to evaluate its validity and potential impact:
Signal Validation: Initial assessment to determine whether the signal is likely to be true or if it could be due to bias or confounding. Signal Prioritization: Determine the public health importance of the signal based on factors such as the severity of the adverse event and the number of people exposed. Risk Assessment: Detailed evaluation of the relationship between the exposure and the adverse event, often involving epidemiological studies. Regulatory Action: Depending on the risk assessment, actions can range from updating safety information to withdrawing the product from the market.
