Archives: Agenda

• Understanding the core principles of responsible AI and how trust, transparency, governance, and human oversight enable successful AI adoption
• Navigating evolving regulatory and ethical expectations to ensure AI systems remain compliant, secure and fit for purpose
• Mitigating AI risks by addressing bias, data quality model validation, and continuous performance monitoring throughout the AI lifecycle
• Scaling responsible AI across clinical development and operations to drive innovation while maintaining patient trust and regulatory confidence

• Embedding patients as equal partners across the medicines development lifecycle
• Building trust through education, transparency and collaborative decision-making
• Strengthening patient engagement to improve clinical research and regulatory decisions
• EUPATI case study: Practical examples of how meaningful patient involvement creates lasting impact

1 stage, a variety of rapid-fire opinions, bold predictions and myth-busting from experts across the industry. Audience members will vote, agree or disagree, on each hot take! There’ll be a chance for the audience to pose some questions to the panel too.

The panel will answer the following:

• Biggest mistake in clinical trials today
• One thing pharma should stop doing
• One prediction for 2030
• What’s overhyped and what’s worth the hype
• What vendors misunderstand
• Where trials fail most often
• Biggest recruitment mistake
• Hot takes from the audience

2 seats available for biotech/ pharma

1 seat available for event sponsor

• Have clinical trials become over-engineered for predictability at the expense of speed, feasibility, and patient access
• Are protocols optimised for regulatory comfort rather than real-world execution and site capacity
• Is clinical trial eligibility criteria too stringent?
• Can adaptive designs, simulation, and AI shift trial design from risk avoidance to smarter decision-making

• Tackling the hidden drivers of patient dropout
• Understanding how participant-focused engagement strategies can improve recruitment, trust, and long-term retention
• When is enough enough, and how much is excessive data collection driving the patients away?
• Identifying why participants disengage during studies and what sponsors and sites can do proactively to reduce attrition

2 seats available for biotech/ pharma

1 seat available for event sponsor

• 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