Archives: Agenda

• Patient driven infrastructure – NF patient registry, NF Preclinical Hub, NF Clinic Network, NF Data Portal – to accelerate trials and insights
• CTF served as IMI research partner on EU PEARL NF1; CTF Europe launched to expand platform trials
• EU PEARL NF1: adaptive platform basket across PN, cNF, LGG/OPG; observational entry → randomization; add/drop arms, early go/ no go signals
• Addresses EMA orphan challenges via clear estimands and central oversight; efficient, de risked paediatric evidence
• NGO impact: contributed to first NF approvals; 60+ US trials; now scaling European execution

• Understanding how multiple systems increase burden for sites and study teams
• Identifying where technology slows down rather than supports trial delivery
• Simplifying workflows across platforms to improve adoption and efficiency
• Reducing friction without removing valuable data and insights

• Understanding how digital tools impact inspection readiness and compliance
• Identifying risks in data integrity audit trails and system use
• Preparing for inspections when using multiple platforms and vendors
• Ensuring teams are aligned on documentation and expectations

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