WILMINGTON, Del., Sept. 14 /PRNewswire/ -- The airline and pharmaceutical industries both provide products and services that benefit mankind but which also can be dangerous if the risks are not properly calculated and dramatically lessened - but can drug manufacturers really learn from the experience of people who make and fly airplanes?
"Yes" is the conclusion of two experts who conducted a recent webinar on the topic - Captain Ben Berman, senior research associate at San Jose State University/NASA Ames Research Center and former chief of major investigations for the National Transportation Safety Board, and Jeffrey Fetterman, CEO of ParagonRx, a Delaware-based company specializing in maximum drug utilization, and author of several books and articles on pharmaceutical risk management. The webinar can be viewed at http://www.paragonrx.com/experience/webinars/pharmaceutical-risk-management-lessons-from-the-airline-industry---august-2009/
"The airline industry has vast experience in risk management systems that drug and devices manufacturers can learn from, especially in preparing FDA-mandated Risk Evaluation and Mitigation Strategy or REMS programs," Fetterman says.
Among the topics discussed in the webinar are how the airline industry concentrates on anticipating and mitigating risks, institutes formal safety management systems and employs redundancies or backups where risks are particularly severe. Earlier this year, Fetterman testified before an FDA REMS meeting on long-lasting opioid drugs and told how one airline safety approach - failure mode and effect analysis or FMEA - has particular relevance to drug safety management for powerful pain medications.
For information about future webinars and other REMS resources, go to www.paragonrx.com.
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