Archives: Agenda

• 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 regulations
• Clinical evaluation pathway
• Definitions for clinical evaluation
• Clinical evaluation procedures
• China localization experience

• 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

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

• Translating past performance data into IVDR-compliant clinical evidence
• Substantiating full intended purpose claims across settings and populations
• Avoiding delays by proactively identifying outdated or missing data