Evaluation of System Design Using Risk Assessment
0
Citation
0
Reference
17
Related Paper
Cite
Cite
Citations (0)
Cite
Citations (0)
Abstract This paper summarizes a project evaluation methodology developed and implemented by Petro-Canada Resources. The two key objectives of the methodology were to improve the technical quality and consistency of evaluations, and to develop measures that would facilitate risk comparisons among different projects. The paper includes a discussion of the actual methodologies and measures, and the implementation process used in introducing the methodology to the organization.
Cite
Citations (0)
Cite
Citations (0)
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).
Cite
Citations (0)
Cite
Citations (0)
Cite
Citations (1)
Cite
Citations (2)