Archives: Agenda

• 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.

• 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

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

Sponsored by Dr. Vince Clinical Research

• 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

• Understand why early patient engagement matters: Explore how patient-focused clinical development can improve the relevance, feasibility and quality of clinical trials.
• Explore the evidence and recommendations of meaningful PRP involvement: Review the 2023 EULAR recommendations and value of involving PRPs from the outset of clinical development.
• Consider how to put patient partnership into practice: Examine practical approaches to embedding PRP involvement in trial design, delivery and evaluation

• How should sponsors allocate resources to accelerate clinical development without compromising quality: Deciding where to build internal capabilities versus leveraging external partners
• Making strategic decisions across processes, technology and quality
• Outsourcing: Which model and when the solution must change
• Convincing the investor: Speed, quality and capital efficiency