Date: 10-12 May, 2023
Location: Park Inn by Radisson Amsterdam City West, Amsterdam, The Netherlands
Language: English
RAPS Euro Convergence is the most comprehensive regulatory affairs conference in Europe, focusing on the latest developments in healthcare products in Europe and beyond—medical devices, IVDs, pharmaceuticals, and combination products.
Gather with European and global regulatory professionals to discover methods that professionals and industries can harmonise through regulatory confluence.
Agenda:
10 May, 2023
- 9:00 AM – 16:00 PM CEST – Bianca Lutters - PMCF Workshop: how to collect valuable data and use it to your benefit?
- 9:00 AM – 16:00 PM CEST – Keith Morel - Risk Management Workshop
- 16:30 – 18:30 PM CEST – Gert Bos and Bianca Lutters - Opening Plenary Session: Leveraging our joint clinical data: the new frontier - a debate on our dreams!
11 May, 2023
- 9:00 – 10:00 AM CEST – Gert Bos – MDCG 2022-14: Game-Changer or 'Shopping List' for MDR Implementation?
- 10:30 – 11:30 AM CEST – Gert Bos, Jorn van Binsbergen and María Cámara Torres – Clinical Evaluation: Measurable Outcome Parameters: Much More Than a Requirement for an MDR-Complaint CER
- 10:30 – 11:30 AM CEST – Danielle Motta – Supply Chain
- 11:45 AM – 12:45 PM CEST – Giovanni Di Rienzo – Clinical assessment: how to minimize the questions from your Notified Body
- 13:45 – 14:45 PM CEST – Sue Spencer – CDx or Not CDx, That is The Question - The Impact of the Clinical Trial Regulation on Tests Used in Pharma Studies and Whether and How the IVDR Applies
12 May, 2023
- 10:45 – 11:45 AM CEST – Giovanni Di Rienzo – Device Lifetime and Lifecycle Management
- 10:45 – 11:45 AM CEST – Kristiane Schmidt – Meeting the EU IVDR PMS and PMPF provisions – setting up an effective PMS/PMPF and reporting system
- 12:00 – 13:00 PM CEST – Gert Bos – Real World Evidence...What Could Possibly go Wrong? A Clinician's Perspective
- 12:00 – 13:00 PM CEST – Giovanni Di Rienzo – UKCA: challenges and opportunities
- 13:15 – 14:15 PM CEST – Bianca Lutters and Inette Nieveen – FDA first, CE later. Clinical and regulatory strategy trends
For more information about RAPS Convergence 2023, please visit the RAPS event website.
Qserve Attendees: