- Piloting practical tools and workflows for collecting high-quality data across international sites
- Navigating local requirements and global compliance for multi-country observational programs
- Integrating imaging, monitoring, and electronic trial master files to strengthen data integrity and site collaboration
Archives: Agenda
PANEL DISCUSSION Coordination assessment processes for medical devices and IVDs
- 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
Choosing the right partner for clinical success
- Decide between full-service CROs, niche providers and consultants
- Map your internal capabilities to your outsourcing needs
- Streamline communication and accountability across vendors
Clinical evaluation for product registration in China (comparison with same type devices)
- Clinical evaluation regulations
- Clinical evaluation pathway
- Definitions for clinical evaluation
- Clinical evaluation procedures
- China localization experience
NETWORKING DRINKS
PANEL DISCUSSION Building and scaling clinical affairs teams with the right expertise
- Balance in-house teams with outsourced or consultant support
- Define key roles from CER writing to PMCF strategy
- Develop career pathways for growing clinical talent pools
Moderator
Dr Sarah Johnson, VP, Head of Clinical Affairs, QIAGEN
End of conference
ROUNDTABLES PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS
During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the medical devices industry.
RT1 Proactive management of safety risks in clinical research
Talia Milosevic, Director, Clinical Safety, Surgical Structural Heart, Edwards Lifesciences
RT2 Structuring your clinical team for efficiency and growth
Dr Stephan Theinert, Head Clinical Development, Eyesense
RT3 Strengthening clinical data reliability and assurance in device development
Anna Mayer, Clinical Auditor, TÜV SÜD
RT4 Fostering positive CRO relationships: tips and best practice
Luca Franceschini, Clinical Project Manager, Aboca
RT5 Practical challenges in managing AI and cybersecurity risks in MedTech
David Bicknell, Principal Analyst, Strategic Intelligence, GlobalData
Sophie Gallagher, Associate Analyst, GlobalData