Pharmacovigilance Signal Detection with Real-World Evidence
How to combine spontaneous ADR reports with electronic health record data to detect safety signals earlier, without drowning your PV team in false positives.
Traditional signal detection leans heavily on spontaneous reporting — and misses much of what real-world clinical practice is telling us. This webcast walks through a proven hybrid approach that blends EudraVigilance and FAERS data with EHR-derived cohorts to surface signals weeks earlier while keeping the noise floor manageable.
We will demo a working detection pipeline, share governance guardrails your QPPV can sign off on, and cover the practical realities of integrating real-world data sources under GVP Module IX revision 2.
Session agenda
Why spontaneous reporting alone leaves too many signals on the table — with numbers.
Architecture walkthrough, EHR cohort curation, statistical thresholds, and QPPV sign-off gates.
Open Q&A focused on GVP Module IX rev 2 alignment and inspection readiness.
What you'll take away
Your speakers
Good to know
No. The demo focuses on decisions and outputs, not code — a PV safety scientist will follow it comfortably.
Attendees receive the governance template under a CC BY-NC licence for internal use.
PASS design is touched on where it intersects with signal detection, but is not the primary focus.
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