Archives: Agenda

• Avoiding over-collection of data that delays timelines without adding value
• Understanding where regulators expect more vs where lean approaches are acceptable
• Sharing real examples of underpowered vs overengineered studies and their impact

• Synchronizing the sponsor, CRO, and site
• Streamlining communication via defined roles and responsibilities
• Stabilizing study teams through proactive, strategic personnel continuity
• Empowering sites with transparent practices and user-friendly solutions

• Reducing site burden without weakening interpretability
• Stress-testing endpoints against missingness and real-world workflow
• Preventing avoidable amendments through feasibility discipline

• The importance of starting clinical design data planning very early—even before product design is finalized—to save time, avoid rework, and reduce budget waste
• How early visibility and alignment across product management/marketing, R&D, and clinical/regulatory prevents misalignment and ensures the design supports meaningful evidence generation.
• A practical shift toward design-linked evidence decisions, focusing on the data that will matter later for claims, regulatory expectations, and real-world adoption

• Assessing the impact of the February 2026 transition from QSR to QMSR on submissions and oversight
• Putting knowledge into practice: updating Clinical Study Plans, budgets and regulatory strategies
• Interactive discussion and Q&A

Workshop Overview:
Six months after the transition from QSR to QMSR incorporating ISO 13485, this practical workshop will examine how medical device teams are applying the new requirements in real-world clinical programs. Participants will explore the regulatory elements shaping clinical trial oversight and practice translating QMSR expectations into submissions and Clinical Study Plans, gaining practical insight into navigating both in-flight and future studies within the evolving global regulatory framework.

• Regulatory strategy development and AI
• Development of the AI FDA Roadmapper^tm.
• Applying the roadmap in practice within clinical development settings
• Navigating regulatory uncertainty when implementing AI across clinical functions
• Outcomes, learnings and key challenges from real-world application