Quantitative Benefit Risk Assessment for the new PSUR & Risk Minimisation 2014

Topics

• Understanding quantitative concepts
• Regulatory expectations for the new psur (pbrer):
  • Compliance
  • Implementation
  • Quality
  • System tracking
  • Links with RMP & Signal detection
  • Auditability
• Statistical methods & data requirements:
  • Safety data
  • Clinical efficacy/effectiveness data
  • Meta-analysis of efficacy and safety data
  • Patient reported outcome efficacy data
  • Preferences and values
  • Statistical signal analysis
• Methodologies of benefit-risk assessment
• Evaluation of the positive and negative effects of additional risk minimisation plans
• Planning for the new psur for new and old products in your company