9:00 am Registration & Morning Coffee
9:30 am Workshop A
Overcoming Regulatory Hurdles to Expand RWE Use in Approvals
Synopsis
Despite growing enthusiasm for real-world evidence, why does its impact on regulatory decision-making still fall short of expectations? What are the key reasons regulators hesitate to embrace RWE for approvals especially in areas like rare diseases? This workshop brings together cross-disciplinary experts to dissect real-world case studies, uncover common pitfalls, and develop practical strategies to align study design, data quality, and methodological rigor with regulatory standards.
This workshop will cover:
- Understand current limitations and slow progress in regulatory acceptance of RWE, especially in rare indications
- Explore successful and unsuccessful examples of regulatory RWE submissions to identify key gaps and learnings
- Co-develop practical strategies for study design, data quality, and stakeholder alignment to improve regulatory receptivity
12:30 pm Lunch
1:30 pm Workshop B
Enhancing HTA & Market Access Success with RWE-Driven Evidence Strategies
Synopsis
Why does real-world evidence often support market access discussions but fall short of influencing final HTA decisions? What’s missing between generating data and demonstrating value to payers, assessors, and economic buyers? This workshop explores how to elevate RWE from a supporting role to a strategic asset in reimbursement and access negotiations.
This workshop will cover:
- Map current use cases of RWE in HTA and market access discussions, including gaps in influencing final decisions
- Discuss what constitutes “fit-for-purpose” evidence from a payer and HTA body perspectives
- Build action plans for cross-functional RWE generation that aligns with the expectations of payers, HTAs, and economic buyers