Risk management is the overall and continuing process of minimizing risks throughout a product’s lifecycle to optimize its benefit/risk balance. Risk information emerges continuously throughout a product’s lifecycle, during both the investigation and marketing phases through both labeled and off-label uses. FDA considers risk management to be a continuous process of (1) learning about and interpreting a product’s benefits and risks, (2) designing and implementing interventions to minimize a product’s risks, (3) evaluating interventions in light of new knowledge that is acquired over time, and (4) revising interventions when appropriate. Pharmacoepidemiology is the study of the utilization and effects of drugs in large numbers of patients. It can be viewed as an epidemiological discipline with particular focus on drugs. The process of identifying and responding to safety issues about drugs. Hence could be applied for Risk management.

Pharmacoepideomology and Risk Management

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