Signal Detection
& Safety
Assessment
Duration: 4 weeks (10 hours)
Can be taken individually: Yes
Learning Objectives
Learners will be able to understand the signal management process from detection to validation and assessment.
Weekly Topics
Week 1: Introduction to Signal Detection
What is a safety signal?
Signal sources
Qualitative vs quantitative detection
Regulatory expectations
Week 2: Disproportionality and Databases
ROR
PRR
Empirical Bayes concepts
FAERS, EudraVigilance, Canada Vigilance, VigiBase
Week 3: Signal Validation and Prioritization
Clinical relevance
Biological plausibility
Strength of evidence
Seriousness and public health impact
Week 4: Signal Assessment and Recommendations
Labeling updates
Risk minimization
Further studies
Benefit–risk implications
Assessment
Signal case study: evaluate a potential drug-event association and prepare a short signal assessment memo.