Mel Munro is Global Lead, Regulatory Science, knoell, UK. She is an experienced veterinary biologicals consultant and manager, with over 20 years in product development - vaccines, biotherapeutics (monoclonals) & novel therapies.
VM2: Novel therapies in animal health – Balancing guidance versus gaining flexibility
The new EU Veterinary Medicines Regulation contains specific provision for novel therapies. Established methodologies for demonstrating quality, safety and efficacy of veterinary medicinal products often cannot be applied to novel therapies.