Archives: Agenda

PANEL DISCUSSION: Bringing the Payer Voice into Clinical Programs: Designing Studies for Approval and Market Access in Rare Diseases

  • Discuss the concept of reimbursable file objectives incremental to regulatory file objectives guiding clinical program development and execution
  • Understand how the market access function is collaborating much more frequently with clinical development teams and why this trend is accelerating
  • Share examples of what ‘good looks like’ and some of the pitfalls, challenges with collaboration between market access and clinical development

Lunch and networking

Concept: This is the practical second half of the workshop, where attendees use real examples to test and refine the trend forecasting framework. Working through guided scenarios, participants will identify signals and translate outputs into concrete decisions.

Takeaway: Attendees will leave having validated the framework through hands-on practice, with a completed sample forecast and a reusable template they can take back to apply to their own clinical data management processes

INTERACTIVE WORKSHOP – PART 1 Building a reliable forecasting framework for clinical data management trends

Concept: This first session introduces a structured, repeatable approach to predicting trends and future needs in clinical data management. Through guided discussion, participants will establish a simple method to score impact vs. likelihood vs. time-to-materialize and connect forecast outputs to practical planning choices

Takeaway: Attendees will leave with a clear, step-by-step forecasting framework that they can use to consistently predict and prioritize what’s next in clinical data management

🗣️ INTERACTIVE BOARDROOM Using AI tools effectively: How can AI existing tools be used better to support data quality without adding complexity?

These collaborative team-building exercises, provide a focused opportunity to work alongside your peers to tackle common clinical data management challenges and develop practical, actionable solutions. Each session begins with a concise 10-minute problem statement presented by the session lead, setting the context and clarifying the key question to solve.

Participants then move into a 30-minute “whiteboard” working session, where each table co-develops a draft framework or potential solution to the challenge. To close, each table briefly summarizes its proposed approach, allowing the wider group to compare perspectives and walk away with multiple actionable solution pathways.