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Signal Detection and Reporting - Coggle Diagram
Signal Detection and Reporting
Validation & Prioritization
Analysis & Assessment
Risk Assessment
Decision-Making
Communication of Safety Information
EMA
MAHs
NCAs
HCPs
Stakeholders
Patients
Monitoring
No action
Need for additional information
Need for a Regulatory Action
PRAC
CHMP
EMA
EC
MAH
Risk Minimization
PRAC
MAH
MAHs
PRAC
EMA
NCAs
NCAs
EMA
HCPs
Patients
MAH