Real-World Data in EU Early Access Programmes: GSK Case Study
Time: 1:30 pm
day: Day 2
Details:
• Defining the minimal dataset that aligns with both regulatory and payor requirements while maintaining feasibility in early access settings
• Addressing variability in RWD collection across EU countries and navigating differing expectations from regulators and health technology assessment (HTA) bodies
• Overcoming data collection limitations in different EAP models, from named-patient programs to broader early access frameworks
