UPIP-VAPI Seminar with FAMHP (after the 2026 General Assembly)

 

 

13:30 Welcome of the participants to the seminar (non members or members who didn't participate to the GA)

14:00 Seminar - Part I: Agency Hot Topics

• Ethel Mertens (General Director of Inspections): the FAMHP some highlights of the future
• Nele Matthijs (FAMHP Head of Distribution Division): The new GDP Webportal
• Latest info on the GMP webportal (K. Froidbise FAMHP Head of Indistry Division
• Katrien Martens (Head of Departmenet DGI MEDDEV): Drug-Device Combinations (Combinatorial Products)
• Karin Froidbise (FAMHP Head of the Industry Division): The Handling of Medical Devices in GMP.

Introduction & news from the Agency

Presentations by AFMPS-FAGG specialists on hot topics such as:

• Current status of the GMP Web Portal & Roll-out of the new GDP Web Portal
• Handling of Medical Devices used in a GxP environment

15h30    Coffee break & snacks – VR Headset demonstration & try-out

16h00: Seminar Part II: Updates of Eudralex Vol IV

• Chapters I (Pharmaceutical Quality Systems) & 4 (Documentation)
• Annexes 11 (Computerized Systems) & 22 (Artificial Intelligence) 

16h30: Seminar Part III: Real-Life examples on the use of AI and VR

Real-life examples on the use of Artificial Intelligence and Virtual Reality:

• Use Case 1: AI Deviation Assistant – Designed to streamline deviation management by writing, assessing risks, and conducting root cause analyses.
• Use Case 2: The use of a Virtual Reality Tool for Training of Aseptic Practices 

18h00:  Afternoon closing and drink

CERPAN Auditorium
Avenue Robert Schuman 211
1401 Nivelles