Regulatory

Showing 9 of 0 results

• Behind the Research: An Exploration of Real-World Data's Ability to Support Adverse Event Surveillance at ISPOR Europe
  • Real-world evidence
  • Machine learning
  • Breast cancer
  • Regulatory
  • Post marketing requirements
• Fit-for-purpose real-world data: Lessons from FDA QCARD and EMA Data Quality Framework

  ISPOR Europe

  • Publication summary
  • Publications
  • Regulatory
• From data to decisions: the role of real-world evidence in recent multiple myeloma drug approvals in the US and EU

  ISPOR

  • Real-world evidence
  • Publication summary
  • Publications
  • Regulatory
• The future of identifying fit-for-purpose real-world evidence for regulatory submissions: A breakdown of the Reagan-Udall Foundation for the FDA QCARD Initiative
  • Real-world evidence
  • Regulatory
• Transporting real-world evidence: Is it possible to transport OS estimates in HER2+ mBC from US to UK

  ISPOR Europe

  • Publication summary
  • Publications
  • Regulatory
• Transportability of overall survival estimates from the US to England in metastatic breast cancer using nationally representative data sources

  ISPOR Europe

  • Publication summary
  • Publications
  • Regulatory
• Evaluation of real-world tumor response derived from electronic health record data sources: A feasibility analysis in mNSCLC patients treated with chemotherapy

  JCO Clinical Cancer Informatics

  • Real-world evidence
  • Non-small cell lung cancer
  • Regulatory
• Assessing real-world data from electronic health records for health technology assessment: The SUITABILITY checklist: a good practices report of an ISPOR task force

  Value in Health

  • Publication summary
  • Publications
  • Data science
  • Methodology
  • Regulatory
  • HTA and market access
  • AP - Blythe Adamson, MPH, PhD
• FDA and Flatiron Health join forces to evaluate real-world outcomes in patients with organ impairment
  • Real-world evidence
  • Article
  • Regulatory