Jan 13 2010
More than 80 Risk Evaluation and Mitigation Strategy (REMS) plans have been approved by the Food & Drug Administration since their inception in March 2008. Now, pharmaceutical companies must formally assess and report on how well these plans have actually been working in reducing drug risks, a mandated step in the REMS process.
This will be the topic of an open industry webinar at 12 noon EST on Wednesday, January 13 entitled "Cracking the Code on REMS Assessments: Opportunities for Improvement and Redesign," It is the second in a series of monthly "Wednesday FoREMS" webinars sponsored by ParagonRx, a subsidiary of inVentiv Health, Inc. and a leading consulting company specializing in pharmaceutical risk management and optimizing medication.
"In many of the discussions we have held with pharmaceutical companies about REMS design and implementation, the most frequent questions we encounter are related to REMS assessment, particularly how to measure the effectiveness of Medication Guides and related communications," says Jeffrey Fetterman, CEO of ParagonRx. "This webinar will help companies better understand how to conduct these REMS assessments."
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