- Working with both cooperative groups and biotechs in a harmonious way
- How to streamline processes and improve trial design
- Avoiding pitfalls which can have lasting global impacts
- Setting up trials for offsite patients and ensuring remote data can be obtained
Archives: Agenda
Registration and refreshments
Joined at the Hip – Regulatory implications of the new Joint Clinical Assessment (JCA) regime
- Understanding how we got here
- Coordinating JCA in parallel to MAA
- How to adapt your oncology strategy to JCA
- What’s next for JCA
Chairperson’s opening remarks
Afternoon refreshments and networking with Apple Prize Draw
CASE STUDY Pediatric Case Study: Insights for Faster, Safer Clinical Trials
Paediatric trials bring amplified risks, tighter regulations, and higher stakes for patient safety – but the lessons learned extend far beyond children’s studies. In this case study, we examine the unique challenges of conducting a paediatric clinical trial and explore how its insights can be applied to improve planning, safety oversight, and operational efficiency in any therapeutic area.
- Navigating Complex Risk Profiles: Managing safety, dosing, and ethical considerations in vulnerable populations.
- Pharmacovigilance in Practice: Meeting rigorous monitoring and reporting demands under high scrutiny.
- Recruitment and Engagement Strategies: Overcoming barriers to participation with patients, caregivers, and advocacy groups.
- Transferable Takeaways: Applying lessons from paediatric research to accelerate and safeguard trials in all therapeutic areas.
Reserved for Event Sponsor
Keynote: Clinical trials in the age of AI – What you’ll discover
Discover how artificial intelligence is transforming clinical research by streamlining processes from protocol design to regulatory submission. This session explores practical AI applications for overcoming recruitment challenges, ensuring ethical implementation, and shaping the future of oncology trials.
- Overcome Bottlenecks: Learn how AI breaks cycle inefficiencies in trial design and patient screening.
- Accelerate Recruitment: See how AI-driven models and molecular matching reduce screening time and failures.
- Implement Ethically: Understand frameworks for bias mitigation, data privacy, and regulatory compliance.
- Future Trends: Explore next-decade innovations like digital twins and foundation models.
Winning the Proof-of-Concept Race Site and Investigator Practical Insights and Tactics on What It Takes to Succeed in Competitive Indications
- The F1 racing concept applied to First-in-Patient protocols
- Strategies to start a study in 6 weeks from submission to first screening
- Real patient recruitment metrics
PANEL DISCUSSION The biotech landscape in Europe 2026: growths, shifts and strategic outlook
- Analysing current market dynamics and funding trends shaping biotech growth in 2026
- Addressing ongoing talent shortages and evolving workforce strategies
- Funding and investment for biotechs in various regions of Europe: how has this shifted in 2026?
- The impact of national political and economic changes on the biotech landscape in Europe