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An innovative approach integrating both expertise in data mining and Pharmacovigilance

A Method

  • Risk Identification and Evaluation
  • Algorithm definition
  • Data extraction
  • KEM™Data mining analysis
  • Results analysis and signal assessment
  • Iterative queries
  • Proposal of corrective actions
  • Implementation and follow-up of corrective or preventive actions

Applied on
  • Aggregate data analysis, PSUR, DSUR
  • Continuous signal detection
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