Signal Management

A statistical method comparing the observed frequency of a drug-event combination against the expected frequency based on overall reporting patterns in a database.

A safety issue that requires urgent reporting to regulators based on new information that may affect the benefit-risk balance of a product.

Safety data from sources outside the company's own database, including regulatory databases, literature, registries, and epidemiological studies.

A potential signal that, after thorough evaluation, is determined not to represent a true safety concern and requires no further action.

Regular documentation of signal detection activities, methods used, signals identified, and their status.

The EMA committee responsible for assessing and monitoring safety issues for human medicines, including signal assessment and risk management recommendations.

A disproportionality measure comparing the proportion of a specific event for a drug versus the proportion for all other drugs in the database.

A disproportionality measure that compares the odds of a specific event being reported for a drug versus the odds for all other drugs.

The process of informing relevant stakeholders (regulators, healthcare professionals, patients) about confirmed safety signals and any resulting actions.

The systematic process of analyzing safety data to identify potential new risks or changes in known risks associated with a medicinal product.

The comprehensive assessment of a validated signal including analysis of all available data to characterize the risk and determine appropriate actions.

A documented plan describing the procedures, responsibilities, and timelines for signal detection, validation, evaluation, and action.

The process of ranking detected signals based on factors such as strength of evidence, potential impact, and public health importance to allocate evaluation resources.

The systematic documentation and monitoring of signals through their lifecycle from detection through evaluation and final outcome.

The process of evaluating whether a detected signal represents a genuine new safety concern warranting further analysis.

A provisional change to product information initiated by an MAH due to new safety information, implemented before regulatory approval.