Archives: Agenda

• Managing increasingly complex clinical trial designs
• Overcoming API availability constraints to enable agile scaling
• Navigating short product shelf-life to ensure reliable delivery to trial sites
• Selecting and tightly managing CDMO/CMO partners to reduce risk and delays
• Ensuring strong alignment with internal stakeholders to accelerate decisions and execution
• Simplifying consumables/component sourcing to reduce complexity and improve continuity
• Mitigating geopolitical and unexpected disruptions to protect supply chain sustainability

• Understanding and complying with regulation to limit delays
• Choosing a manufacturing and distribution model to suit trial supply
• Considering temperature monitoring and control options to reduce excursions and waste
• Reviewing challenges faced and lessons learnt

Clinical development has fundamentally changed, yet many supply chain models have not. This session explores why a strategic shift is required to secure patient access, control costs and sustain performance in an increasingly uncertain world.

Strapline: Cutting through the noise to drive measurable value

• Market outlook: investment signals, consolidation, and risk priorities

• AI – separating hype from tangible results

• Establishing a use case – the difference between failure and success

• Investment priorities: where should you invest?

Concept

Participants work through a real inspection finding scenario using an interactive training approach that combines regulatory requirements, audit observations, and AI-supported decision-making.

Takeaway: Transferable methodology for training teams to prepare for inspections using AI while maintaining audit trail and regulatory compliance.