Signal management process is a set of activities that are performed to determine whether there are new risks associated with a medicinal product or known risks have changed based on the examination of Individual Case Safety Reports (ICSRs), aggregated data from active surveillance systems or studies, and scientific literature information or other data sources. It also includes related recommendations, decisions, communications and tracking. In such scenarios, a signal strategy must be adapted to address every medicinal product’s safety profile, it’s stage in the lifecycle, and must line up with a precise risk-based signal management process to guarantee proper signal prioritization, escalation and timely decision making. The signal management process includes the following activities: signal detection, signal validation, signal confirmation, signal analysis and prioritisation, signal assessment and recommendation for action.
With an expert safety team, Freyr strategizes and implements the best risk mitigation plans and analyzes to understand safety information for early signal detection. Freyr is specialized in implementing a fool-proof signal management process right from signal detection to evaluation.
- Global safety database line listing and summary tabulations for signal detection
- Quantitative signal detection using disproportionality analysis
- Qualitative signal detection using a case by case analysis
- Review of individual case safety reports, aggregate reports as well as PRAC recommendations on safety signals, safety updates in the health authority websites and literature review for evaluation of safety information
- Identification of a new safety signal or a change in risk associated with a medicinal product
- Validating identified safety signal and review process such as determination of causality, evaluation of frequency and strength of evidence for a causal effect
- Accurate interpretation of safety data and confirming the signal in coordination with the safety committee of MAH periodically
- Signal assessment and recommendations, which includes risk classification and proposals for risk minimization measures
- Risk management strategy development, planning, execution and evaluation
- Use of tools for signal detection activities and signal management tracking