How Manufacturers Can Strengthen RWE Submissions for Optimal Use in Regulatory and Reimbursement Decision Making

February 12, 2024 11:00am

Dr. Nicole Mittmann
Chief Scientist and Vice President, Scientific Evidence, Methodologies and Resources
CADTH

David Shum
Director, Strategic Access and Pricing
Roche

Moderator:

Brad Millson
General Manager
Real World Solutions
IQVIA

  • Identifying acceptable sources of real-world data
  • Examining how regulators and HTA bodies are using RWE in decision-making about the safety and efficacy of drugs
  • Aligning RWE submissions with HTA expectations
    • Understanding how RWE is being assessed
      • Determining what is considered a sufficient level or proof or value proposition for recommendations
    • Applying RWE reporting best practices to expedite reviews and maximize relevance of submissions