This session will focus on the Veterinary Medicinal Products Regulation (NVR, Regulation 2019/6) and its practical implications. The program will include presentations from various speakers covering topics such as parallel distribution/import, pharmacovigilance, and an overview of the updated legislation and related procedures (regulatory, publicity, quality, GDP, samples, and clinical trials). The session will also address inspection and good practice, and highlight areas where the industry can further improve compliance with the new regulatory requirements.

Program:

• 08:30-09:00 – Welcome & registration coffee
• 09:00-09:40 - Wout Cattrijsse (FAMHP): “Veterinary Publicity: EU & National Legislation” 
• 09:40-10:00 - Cédric Maerckx (FAMHP): QRD update – How to go forward quickly and efficiently? 
• 10:00-10:20 - Els Dewaele (FAMHP): Pharmacovigilance in a nutshell
• 10:20-10:45 - Coffee break
• 10:45-11:10 - Cédric Maerckx (FAMHP): Explanation of the Royal Decree of 29/05/2024 concerning clinical trials 
• 11:10-11:30 - Sarah Hamels (FAMHP): An overview on parallel trade in Veterinary medicinal products
• 11:30-12:00 - Pieter Jan Serreyn (Animal Health Europe) Animal Health industry in EU & impact of Regulation