Archives: Agenda

• Shifting Phase IV from an operational to a strategic function within broader evidence generation and lifecycle planning
• Building reusable evidence platforms rather than relying on fragmented, one-off studies
• Exploring the growing role of external control arms alongside the challenges of data quality and regulatory acceptance
• Selecting the right outsourcing model to support long-term evidence generation and the future evolution of Phase IV programmes

• Key recurring GCP findings identified in recent Swissmedic inspections
• A Swissmedic perspective on ICH E6(R3), Real-Time Monitoring and evolving regulatory expectations
• Common gaps in oversight, documentation, and trial master file (TMF) management
• Frequent issues in vendor/CRO oversight and delegated responsibilities
• Practical recommendations to strengthen inspection readiness and quality systems

With drinks and refreshments, interactive breakout sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Each discussion will run for 30 minutes and be led by a table moderator and will focus on a different challenge within clinical trials. Breakout discussions are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

Chair: Available

• Exploring how AI can support end-to-end clinical trial delivery, from protocol authoring and risk assessment through to data analysis and reporting
• Examining how historical trial outcomes, regulatory feedback, and operational data can be leveraged to improve planning, country selection, site strategy, and database design
• Understanding how AI-driven connectivity across departments can break down silos and create a more integrated approach to trial execution
• Discussing how organisations can operationalise AI strategically to future-proof clinical development processes rather than applying disconnected point solutions

Moderator: Andreas Panteli, Director, Clinical Trial Recruitment/ Operations, Novartis

• Looking at why Europe is losing competitiveness and risks falling behind in trial attractiveness and patient access despite advanced healthcare systems and strong research reputations
• What must change for Europe to remain desirable, including initiatives shaping the future European landscape (FAST‑EU, COMBINE, EU Biotech Act)
• Examining the rise of emerging trial destinations, from China to the Middle East, alongside the ethical responsibilities and more favourable regulatory approvals
• Exploring the role of ISO 18969 in harmonising clinical investigation processes and supporting more efficient trial delivery across Europe

Moderator: Juliet Dizon, Director, Pre-Clinical and Clinical Quality Assurance, ARTBIO

1 seat available for event sponsor

• Understanding the link between European competitiveness, trial attractiveness, and patient access
• Examining how site capacity constraints are reshaping the clinical trial landscape
• Exploring what differentiates sponsors that sites and patients actively choose to work with
• Assessing how trusted partnerships can accelerate study delivery and bring innovation to patients faster