From the Seven Deadly Sins to a Risk Management Plan.

The author considers the creation of a risk management plan (RMP). He cites the factors affecting a spontaneous reporting system according to W. H. W. Inman, one of the fathers of modern pharmacoloepidemiology. He discusses the aspects of the Yellow Card Scheme and Prescription Event Monitoring (PEM) in Great Britain. He mentions the Risk Minimization Action Plan (RiskMAP) released by the U.S. Food and Drug Administration.