The biopharmaceutical industry has many challenges including technical,organizational and societal. This fast paced industry is continuously buffeted by new productdevelopments, technological changes, as well as evolving patient requirements and aggressiveindustry competition. To help address these many challenges an approach was developed using offthe-shelf tools (Excel, Primavera and Pertmaster) to achieve a standard and straightforwardmethodology to insure consistent, reliable risk management and establish a basis for continuousmanagement of risks throughout the project life. Benefits include a clear and easy to use riskregister with responsible risk owners and risk ranking for focus and mitigation; simulation ofproject cost and schedule impact via project risk models to facilitate decision-making; promotion ofactive participation from a diverse user group, and the opportunity to focus the combinedknowledge and experience of the team to enhance project performance. This approach ultimatelytransformed risk management from a negative paradigm into a positive, synergistic, team building,group educating, and solution-generating experience.
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