Master in Regulation and Evaluation of Medicines and Health Products

Veterinary Medicinal Products

ECTS

5

Learning outcomes

Learning the differences between human and veterinary medicines.
Learning the rules governing veterinary medicinal products in European Union.
Learning the different guidelines for e.g., establishment of maximum residues limits in foodstuffs of animal origin. Learning to elaborate a dossier for a veterinary medicinal product
Leaning to assess a veterinary medicinal product

Syllabus

Main topics
Human – Veterinary medicinal product
Regulatory-Assessment Framework
Veterinary drugs evaluation – antiparasitic; quality issues; markt of veterinary medicinal products and its distribution; antimicrobial assessment; the use of antimicrobials and its impact; the CVMP strategy on antimicrobials 2011-2015; safety assessment of Veterinary Medicinal Products – the residues; the relevance and assessment of vaccines in veterinary medicine; the environmental impact of Veterinary Products; the integrate safety risk-analysis of Veterinary Medicinal Products.

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