Archives: Agenda

• Design trials that support both CE marking and joint clinical assessment
• Anticipate payer expectations when choosing clinical endpoints
• Avoid duplicative evidence generation by aligning early

• Create lean survey strategies that deliver quality insights
• Integrate PSURs, CERs and PMCF into a manageable system
• Reduce documentation burden without losing regulatory value

• Examining the “business behind clinical” and how operations leaders can demonstrate ROI, efficiency, and scalability
• Meeting regulatory expectations while supporting commercial growth
• Translating clinical results into business impact: internal KPIs that matter
• Creating adaptable infrastructure for long-term clinical evidence generation

• Exploring options when traditional clinical data requirements cannot be fully met at submission
• Establishing a robust clinical strategy using early dialogue, risk-based justification and post-market commitments
• Leveraging expert panels, NB consultations and scientific advice to de-risk approval pathways

Moderator: Dr. Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

• Sharing a practical case study on using retrospective clinical data to meet evidence requirements for CE marking
• Demonstrating how to align historical data with current MDR expectations for robust clinical evaluation
• Highlighting lessons learned, common pitfalls, and tips for ensuring Notified Body acceptance

• Future-proof your CERs against class shifts and MDR updates
• Address challenges when intended purpose evolves with technology
• Build defensible clinical arguments for AI-enabled systems