The signal management process is a legal obligation for pharmaceutical companies.
The process includes the following steps:
- Signal detection
- Signal validation
- Signal prioritization
- Signal assessment
- Recommendation for action
- Exchange of information
One of the most critical and time-consuming steps is signal detection. Outsourcing this activity to our team can save you time while providing you with high-quality results.
Indeed, we follow the European Medicines Agency (EMA)’s recommendation when performing periodical signal detection and we adapt the methodology to the medicinal product risk profile. We use both qualitative and quantitative analysis methods, including Standardised MedDRA Queries (SMQs). We also look at specific types of adverse events, population groups, or circumstances of medicine uses (eg. off-label practices, medication errors, etc…).
« When properly performed, signal detection can be compared to a lighthouse, which will guide your path and prepare you for what is ahead. »
Do you want to learn more about the signal detection process in pharmacovigilance? Click here: https://www.pharmacovigilanceanalytics.com/signal-detection-management/
Do you want to learn more about how SMQs are used to support signal detection? Click here: https://www.meddra.org/how-to-use/tools/smqs
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