Archives: Agenda

• Designing an FIH study to generate an early proof-of-concept signal alongside safety and tolerability data
• Selecting FeNO as a practical biomarker to rapidly assess anti-inflammatory activity in asthma patients
• Demonstrating a 50% reduction in mean FeNO after just three days of treatment while maintaining minimal systemic exposure
• Exploring the operational decisions that enabled rapid assessment of healthy volunteers and asthma patients within the same early-phase programme
• Translating early clinical and biomarker data into clear evidence to support the next stage of development

• Understanding how clinical trials continue during war and infrastructure disruption
• Managing patient safety supply chain and data integrity under extreme conditions
• Applying lessons from Ukraine to improve resilience and contingency planning

• Concept: This session explores how different patient personalities, preferences and behaviours can shape the way they receive information, ask questions and engage with a clinical trial. Through guided discussion and practical examples, participants will identify common communication styles and consider how to recognise individual needs without relying on assumptions.
• Takeaway: Attendees will leave with a practical framework for recognising different communication preferences and adapting their approach to build understanding, trust and engagement with patients.

Clinical outsourcing generates more data than ever—but are we actually getting smarter at using it? This session explores how intelligence can transform the vendor management lifecycle: enabling smarter sourcing and category strategies, continuous governance and performance management, stronger ICH E6(R3) compliance, and greater inspection readiness. We’ll look beyond the AI hype to practical ways of connecting data, context, and human expertise to anticipate risk, improve decisions, and move clinical outsourcing from reactive oversight to proactive foresight.

• Exploring initiatives like Trial Nation
• Understanding funding structures
• Deciding when they add value

• 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

• What have Member States done to harmonise procedures
• Templates and Procedures developed e.g pre-CTA
• FAST EU and Fast track for early phases