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June 8, 2011

Risk Evaluation and Mitigation Strategies (REMS) Assessments: New Data Analysis Tools for Assessing Performance Understanging REMS assessment performance variables and Medicaiton Guide effectiveness

A periodic assessment of patient and/or healthcare provider understanding of the risks associated with the use of a product is a requirement of every approved REMS program, but is fundamentally challenged by limitations in interpreting the relative performance of the resulting assessment scores and values. This places a pharmaceutical manufacturer in the difficult position of subjectively stating the effectiveness of the REMS in achieving its goals and the need, if any, for corrective actions. ASSESS is a novel registry and analytical tool used for examining the influence of multiple variables on REMS assessment results to help determine acceptable performance thresholds. This presentation demonstrates the applicability of the ASSESS tool and utilizes case studies to show examples of:

  • Measuring the effectiveness of Medication Guides
  • Establishing meaningful benchmarks to inform corrective actions
  • Understanding the variables that influence REMS assessment performance scores
  • Applying new analytical methods for interpreting a REMS assessment

Guest Presenter:
Larry Risen, President - BioTrak Research


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