Upcoming webcastRegulatory Compliance
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.
Host & moderator
Sofia Martel
Senior Pharmacovigilance Scientist · Sanofi
Date
Wed 5 Aug 2026
Time
14:00 UTC
Duration
75 min
Price
Free
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FreeRegister once — attend live or watch the replay.
About this session
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
14:00 – 14:15
The signal detection gap
Why spontaneous reporting alone leaves too many signals on the table — with numbers.
14:15 – 14:50
Building the hybrid pipeline
Architecture walkthrough, EHR cohort curation, statistical thresholds, and QPPV sign-off gates.
14:50 – 15:15
Q&A and governance clinic
Open Q&A focused on GVP Module IX rev 2 alignment and inspection readiness.
What you'll take away
1
Where spontaneous reporting alone falls short in modern PV programmes
2
A hybrid signal detection architecture using EHR-derived cohorts
3
GVP Module IX rev 2 expectations for real-world data governance
4
How to keep the false-positive rate in check for your PV team
5
A demo pipeline you can adapt in-house
Your speakers
Host
Sofia Martel
Senior Pharmacovigilance Scientist · Sanofi
Panelist
Dr. Jonas Lindqvist
Global Head, Clinical Compliance · AstraZeneca
Good to know
Do I need a data science background to follow the demo?+
No. The demo focuses on decisions and outputs, not code — a PV safety scientist will follow it comfortably.
Are the templates shared under a specific licence?+
Attendees receive the governance template under a CC BY-NC licence for internal use.
Does this cover post-authorisation safety studies (PASS)?+
PASS design is touched on where it intersects with signal detection, but is not the primary focus.
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