This document discusses pharmacovigilance, which involves monitoring the safety of medical products. It defines pharmacovigilance and outlines its history, purpose, and key processes. These include collecting adverse event reports, detecting safety signals, evaluating risks, and implementing risk minimization measures. The document also discusses challenges such as distinguishing true safety signals from background noise and standardizing signal evaluations.
7. Pharmacovigilance process
Data
Collection
Signal
Detection
Evaluation
Communication
Intervention
• Post marketing spontaneous
reporting (ADR reporting
system)
• Clinical development and
pharmacology studies
• Interventional and
Observational studies
• Epidemiology data and
registries
• Pre-clinical information:
animal, toxicology and
pharmacology information
• Literature
• Web, blogs, social networks…
• Statistical analysis
• Disproportionality
analysis
• Cluster detection
analysis
• Quantitative strength
of association (time
to onset, biological
plausibility)
• Safety aggregate reports
• Risk management plan
• Dear Healthcare Provider Letter
• License Renewal
• Label change
• Marketing authorisation
withdrawal or cancellation
• Causality assessment
of the Individual Case
Safety Report
• Signal evaluation
• Benefit-risk evaluation
• Risk management
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