Archives: Agenda

• Modern FDA Acceleration Pathways: Breakthrough, Fast Track, Accelerated Approval, Priority Review, RTOR, Orbis, CNPV
• Trial Design Innovations That Regulators Support: adaptive designs, master protocols, biomarker‑driven enrichment
• Optimizing Early Regulatory Engagement to Enable Acceleration: strategic FDA/EMA interactions, alignment on endpoints and biomarkers

During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

Navigating communication styles by tailoring approaches for different patient personalities
Roel van der Heijde, Facilitator & Trainer, Patient Experience Association The Netherlands

Managing Clinical Trial Budgets in An Unstable Financial World

Working Better with Investigative Sites

Working With CROs More Effectively

• Sharing real examples of decisions that led to delays inefficiencies or trial failure
• Understanding early warning signs that were missed or ignored
• Identifying what should have been done differently in hindsight
• Applying these lessons to improve future trial design and execution

3 x Biopharma panel seats available

1 x Vendor panel seat available

• Insights from the Nordic Patient Empowerment Survey (Nordic Rare Disease Summit 2025) and the Danish Rare Disease Survey (Guldkundeunders gelsen 2025) and their relevance for clinical trial design and patient engagement
• Building trust and improving communication to support participation in healthcare and clinical research
• Understanding the practical barriers faced by people living with rare diseases and how they may influence clinical trial participation
• Moving from consultation to partnership: patient perspectives on involvement and decision-making throughout the research journey
• Leveraging insights from Nordic patient organisations to better understand patient needs and priorities in rare disease research