Lifecycle approach to medical devices

This is a session to discuss how we can improve "Safety Notice & Vigilance" to be more efficient and effective for manufacturers, regulators and healthcare providers. Each stakeholder will present concerns and propose ideas to improve current situation and discuss at the panel session.

• Opportunities and challenges: Regulator’s perspective - Melissa Torres and Christophe Driesmans
• Opportunities and challenges: Industry perspective - Nicole Smith and Miang Tanakasemsub
  
• Opportunities and challenges: Healthcare professional perspective - You-kyoung Lee and Timothy Wilton
  
• Panel discussion: Opportunities for improvement - moderated by Paul Piscoi

This is a session on real world evidence aims to describe the means through which real world evidence can be gathered and validated and which are the appropriate uses of real-world evidence within a regulatory context.

• Status of Global Acceptance of RWD/RWE in regulatory activities and lessons learned from various regions - Heather M. Colvin
• RIVD perspective and examples of RWD/RWE - Elodie Baumfeld Andre
• How to incorporate real-world data sources into regulatory decision-making processes? - Tom Melvin
• Uses of real-world evidence - Erin Cutts, Sabina Hoekstra and Lyu Yunfeng
• Panel Discussion - moderated by Heather M. Colvin and Donal O'Connor

• PMS for software: apped if you do, apped if you don’t - Kees Maquelin
• Challenges and opportunities in collecting or generating data for digital MDs - Pat Baird
• Common post-market issues faced with software and how to address them? - Rolf Oberlin Hansen
• Panel discussion moderated by Nada Alkhayat and Jesús Rueda Rodríguez

• Monitoring of endpoints (surrogate and non-surrogate) - Leo Hovestadt
• Bias in the post-market phase - Anindita Saha and Pat Baird
  
• Change management - Rama Sethuraman and Melissa Finocchio
  
• PMS for AI software - Lesley-Anne Farmer and Hae Ung Lee
• Panel Discussion moderated by Matthias Neumann and Jesús Rueda Rodríguez