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RAPS Euro Convergence 2025
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Event details
RAPS Convergence is the largest and most recognized event for regulatory professionals, bringing together industry leaders, innovators, and experts from around the globe. The congress is a platform for sharing the latest developments, best practices, and cutting-edge insights in regulatory affairs. With a diverse agenda of workshops, panel discussions, and networking opportunities, RAPS Convergence is where the future of regulatory science and practice takes shape.
What we'll cover
- New International Submission Routes: Peter Fry shares insights and lessons learned from navigating the latest UK submission pathways for regulatory approval.
- Companion Diagnostics: join Kirsten Van Garsse, Sara Van Wouwe, and Warren Jameson for an in-depth discussion on the evolving landscape of companion diagnostics and their critical role in personalized medicine.
- Large Panel Genomic Profiling and IVDR Strategies: explore practical strategies for manufacturers with Steven Van Hove and Annelies Rotthier or Pieter Bogaert (TBD), alongside James Kerr and colleagues, as they tackle the challenges of large-panel genomic profiling under the IVDR framework.
- EU IVD Performance Studies: Sara Peeters, Morgot Borgel, and Sven Hoffmann delve into the requirements and methodologies for conducting performance studies under the EU IVD regulation.
- ISO 81001-5-1 Implementation: gain expert insights from Pieter Smits, Julian Alpers, and Kevin Veldman on the implementation of ISO 81001-5-1 and its implications for quality and risk management in medical device software.
Meet our experts at RAPS Euro Convergence 2025!
We're proud to announce that several QbD Group colleagues will be sharing their insights on stage at this year's RAPS Euro Convergence. From regulatory strategy to clinical evaluation and digital health, don’t miss their expert talks throughout the event!
Annelies Rotthier
📅 Thursday, 15 May 2025
⏰ 08:30 – 09:30 CEST
📍 Studio 211 + 212 (level 2)
🎤 "Large Panel Genomic Profiling and IVDR Strategies for Manufacturers".
Join Annelies alongside James Kerr (BSI), Prof. Els Dequeker (UZ Leuven), and Divera Pronk (Hartwig Medical Foundation), as they tackle the challenges of large-panel genomic profiling under the IVDR framework.
Kirsten Van Garsse
📅 Wednesday, 14 May 2025
⏰ 10:45 – 11:45 CEST
📍 Studio 214 + 216 (level 2)
🎤 "Addressing the Complexities of Using in Vitro Diagnostics (IVDs) in Global Clinical Trials"
📅 Friday, 16 May 2025
⏰ 11:45 – 12:45 CEST
📍 Copper Hall (level 0)
🎤 "Involving European Reference Laboratories in the Conformity Assessment of Class D IVD's: Operational Update After 6 Months"
Book a meeting with our life sciences consultants
In addition to our speakers, QbD Group’s business development experts will also be attending the event. If you’re exploring regulatory support, EU market entry, or want to discover how we can support your product journey from A to Z - don’t hesitate to book a meeting.
Meet us at RAPS Euro Convergence 2025 or reach out today to schedule a conversation!
Jens Vandormael
Jens Vandormael has extensive experience in business development within the pharmaceutical sector, currently serving as a Senior Business Development Manager at QbD Group since September 2017, after holding various related positions including Business Development Manager and Project Consultant. Additionally, Jens is an active member of the ISPE Belgium Affiliate emerging leaders board since April 2022, contributing to advancements in pharmaceutical engineering. Prior to these roles, Jens was involved as a Tutor at Sagio.be VZW and as a Master Thesis Student at KU Leuven, focusing on the development of an optical fibre surface plasmon resonance method for monitoring the solubility of aptamer-based medicines. Jens was also a board member of LBK, a student association dedicated to education, during 2016-2017. Educational background includes a degree from KU Leuven, completed in 2017.
Bernd Lafortune
Looking to discuss your IVD challenges? Let’s connect at RAPS Euro Convergence 2025!
Or come and visit us at one of our other events
Can’t make it to this one? No problem! We’re always on the move, sharing insights and connecting with industry professionals.
Check out our upcoming events and find the perfect opportunity to meet us in person. We’d love to see you there!
Get in touch
Have a question or need more information? We’re here to help! Fill out the form and our team will get back to you as soon as possible.
Let’s start the conversation!
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