Regulatory

Showing 9 of 0 results

• RWE Submission for European Regulators and Payers: Challenges, Uncertainties, and Opportunities

  Ther Innov Regul Sci

  • Publication summary
  • Publications
  • Regulatory
  • HTA and market access
• A feasibility analysis to align fit-for-purpose real-world data to emulate the AZUR-1single-arm clinical trial in patients with dMMR/MSI-H locally advanced rectal cancer

  ASCO GI

  • Publication summary
  • Publications
  • Precision medicine
  • Colorectal cancer
  • Regulatory
• Utilization of real-world evidence in regulatory approvals for multiple myeloma therapies

  Blood Cancer Journal

  • Publication summary
  • Publications
  • Multiple myeloma
  • Regulatory
• 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