ABSTRACT
Risk management is a concept of growing attention not only in the pharmaceutical industry but also in other industries. In general terms, risk management can be dened as “The identication, assessment, and prioritization of risks followed by coordinated and economical application of resources to minimize, monitor, and control the probability and/or impact of unfortunate events“ (Hubbard 2009, p. 10). of risk assessment and risk minimization according to the U.S. Food and Drug Administration (FDA) (U.S. Food and Drug Administration 2005a). The FDA underlines further, “risk management is an iterative process of (1) assessing a product’s benetrisk balance, (2) developing and implementing tools to minimize its risks while preserving its benets, (3) evaluating tool effectiveness and reassessing the benet-risk balance, and (4) making adjustments, as appropriate, to the risk minimization tools to further improve the benet-risk balance.” Similarly, the European Medicine Agency (EMA) denes a risk management system as a “set of pharmacovigilance activities and interventions designed to identify, “characterize, prevent or minimize” risks relating to medicinal products including the assessment of the effectiveness of those activities and interventions” (European Medicine Agency 2012).
