Presenting Post-Market Safety Signal Data to European EMA Regulators
When real-world registry data detects a potential drug interaction signal, presenting safety surveillance to European Medicines Agency (EMA) officials requires epidemiologic rigor.
Amit KasliwalCEO & Founder, Dehurdle
March 18, 20234 min read
The Pharmacovigilance Risk Management Presentation
Recommended Spoken Script
"Across 140,000 patient-years of commercial exposure, the observed-to-expected incidence ratio for hepatotoxicity is 1.04, matching background population rates. To ensure proactive physician awareness, we are submitting an updated Summary of Product Characteristics (SmPC) with quarterly liver function monitoring guidelines."
The 2-Minute Practice Drill
2-Minute Spoken Drill
The 2-Minute Practice Drill
Practice pharmacovigilance regulatory briefings in Dehurdle.