Archives: Agenda

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

Most Sponsors and CROs have made the move to RBQM at an operational level – but is the approach actually intelligent, or is it still driven by manual review cycles, static risk thresholds and teams buried in reporting?

• Moving from operational RBQM to AI-enabled RBQM that learns, adapts and surfaces the right signals before they become issues
• Identifying where operational RBQM is still leaving value on the table and where AI can create a step change in quality and efficiency
• Examining what the data shows about improvements in speed, accuracy and cost
• Achieving real-time inspection readiness for Sponsors and building a quality capability that helps CROs win and retain business

• Understanding how the new UK framework is working in practice 6 months after implementation
• Identifying key operational changes, including approvals, consent, and trial setup
• Clarifying how sponsors can take advantage of faster pathways while staying compliant

• Exploring the meaning of risk sharing across roles
• Supporting balance between procurement and R&D priorities
• Strengthening partnership models through transparency

Moderator

Alexander Booth, Host, Lab to Lives Podcast

• Defining clear roles and responsibilities between sponsor and CRO to avoid duplication and gaps
• Identifying what sponsors should actively oversee versus what can be delegated with confidence
• Setting oversight models that focus on risk rather than excessive monitoring
• Improving communication and escalation pathways to prevent delays and misalignment