Archives: Agenda

• Understanding the updated competent authority application pathway for CDx under IVDR
• Sharing lessons learned from real-world submissions and post-application interactions
• Identifying best practices for aligning diagnostic and therapeutic regulatory timelines when engaging with authorities

• Spotting compliance risks early for novel or AI-enabled devices
• Best practices for bridging clinical and regulatory teams
• Lessons from recent reviews and practical recommendations for sponsors

• Discussing lessons learned from coordinated assessments for medical devices under Article 78
• Considering the impact of the European Commission’s pilot project for IVD stakeholders
• Sharing practical approaches for preparing evidence packages and coordinating with multiple authorities during assessments

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

• Decide between full-service CROs, niche providers and consultants
• Map your internal capabilities to your outsourcing needs
• Streamline communication and accountability across vendors

Topic TBC