You can find the presentations that were given at workshops and symposia at the FAMHP here.
Study day in-house medical software for healthcare institutions - 10.03.2026
- Introduction - Prof. Pascal Verdonck (Belgian Association of Hospital Managers) (PDF - video)
- Qualification and Classification of Medical Device Software - Koen Cobbaert (Philips) (PDF - video)
- Introduction to the MDR and the European Regulatory Landscape for Medical Device Software - Stef Rommes (VITO) (PDF - video)
- Regulatory Pathways for Medical Device Software Developed by Healthcare Institutions
- Panel discussion (video)
moderated by Valerie Nys (Federal Agency for Medicines and Health products) with Dr. Maxime Griot (UCLouvain), Alexander Olbrechts (MedTech Europe), Nick Marly (Cabinet Minister Vandenbroucke), Prof. Tom Goffin (Ugent)
Symposium on vaccines - 05.09.2025
- Welcome (and agenda presentation)
- The FAMHP strategy for vaccines and the Vaccines Centre of Excellence
- The vaccine clinical trials in Belgium and in EU
- Sponsor’s perspective: Belgium as a vaccine clinical trial hub
- Site’s perspective: Belgium as a vaccine clinical trial hub
- Ensuring Safety: Best Practices in vaccine clinical trial monitoring
- Vaccine-related National Scientific-Technical Advice (STA) and Simultaneous National Scientific Advice (SNSA) requests
- Clinical principles for vaccine licensure and monitoring - 1
- Clinical principles for vaccine licensure and monitoring - 2
- Real-world evidence generation and use for regulatory and public health decisions on vaccines: EMA perspective
- Superior Health Council: ways of working and latest recommendations
- Recommendations for pneumococcal vaccination in children