Systematic signal detection, assessment and risk management services — helping you meet GVP Module IX, CDSCO requirements and EU-RMP obligations.
Discuss Signal Detection NeedsA safety signal is information that arises from one or multiple sources — including observations and experiments — which suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an event or set of related events, either adverse or beneficial.
GVP Module IX (Signal Management) requires MAHs to maintain a signal detection system, validate and prioritise signals, conduct full signal assessment, and implement appropriate regulatory action. In India, CDSCO expects MAHs to document their signal detection methodology in the PvMF and report validated signals to regulators.
A structured six-stage approach from detection to regulatory action
Disproportionality analysis using PRR, ROR and IC algorithms applied to cumulative ICSR data and literature findings.
Clinical and scientific evaluation of the statistical signal to determine if it represents a genuine, previously uncharacterised safety concern.
Risk-based ranking of validated signals for triage: immediate action required vs. routine assessment vs. monitor.
In-depth case-by-case analysis, literature review, and epidemiological context evaluation. Output is a Signal Assessment Report.
Regulatory reporting to CDSCO, EMA or FDA as required. Labelling updates, DHCPLs, or Risk Minimisation Measures initiated.
All signals documented in a Signal Tracking Register. Outcomes recorded in PvMF and PSUR/PBRER signal sections.
A Risk Management Plan is a pharmacovigilance planning document that describes the known and potential risks of a medicinal product and outlines measures to prevent or minimise these risks in the target patient population.
Structured per EMA GVP Module V. Covers safety specification, pharmacovigilance plan, risk minimisation measures, and PASS obligations. Submitted with marketing authorisation applications and updated periodically.
US FDA requirement for products with serious risks that require additional safety measures beyond standard labelling. May include Medication Guides, restricted distribution programmes (ETASU), or communication plans.
Observational or interventional studies conducted post-approval to characterise or quantify known safety risks, or to investigate signals identified during routine pharmacovigilance.
Contact our PV team for a free consultation on signal management and risk planning.
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