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ProjTitle.icon P.II.B.5. Signal management

Signal management process is a set of activities performed to determine whether there are new risks associated with an active substance or a medicinal product or whether known risks have changed, based on ICSRs, aggregated data from active surveillance systems or studies, literature information or other data sources (GVP Module IX). Signal management process performed on registered product used in Saudi Arabia. These products include prescription medicines, over-the-counter medicines, complementary medicines, as well as biological products. This section should be followed alongside the general guidance in GVP Module IX on signal management. Pregnancy PV aims to detect signals that might indicate that a particular drug is associated with adverse pregnancy outcomes. Pregnancy-related signals may also include compliance with pregnancy prevention programs and with pregnancy as a labeled contraindication. The signal management process from signal detection to recommendation for action is provided in GVP Module IX.

P.II.B.5.1 Signal detection: Spontaneous reporting

The identification of related cases plays a vital role in supporting signal detection and validation. In order to retrieve all pregnancy outcomes (such as congenital anomalies, spontaneous abortion, stillbirth, and labor complications), the Standardized MedDRA Query (1st level) Pregnancy and neonatal topics' may be useful.

As general PV, an individual clinical assessment of each report is the main strategy for detecting signals in spontaneous pregnancy reports. This method includes checking detailed information (e.g. timing of gestation, duration, and product) regarding exposure during pregnancy, reviewing product information, searching national and global ADR databases for similar reports, and reviewing reference sources and medical literature for previous cases and other relevant information.

P.II.B.5.2 Signal detection: Cohort event monitoring

A cohort event monitoring program may help detect a certain type of signals regarding the prevalence and safety of certain medications during pregnancy.

A comparative cohort study can compare the prevalence of adverse pregnancy outcomes between exposed and unexposed women (with or without the same or similar diseases). Generally, cohort event monitoring uses aggregate data analysis.  (Lareb, Pregnancy PV Toolkit).​

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