The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA

This intensive four-day course provides a thorough understanding of how to develop a veterinary medicine in the EU and USA.

The development of a veterinary medicine is complex, time consuming and expensive. It requires teamwork from individuals with different scientific training and a wide range of skills. Everyone involved must be aware of the main stages in the development programme and be able to relate his or her responsibilities to the expertise and needs of the scientists and commercial members of the team. Furthermore, different approaches taken by the regulatory authorities in the EU and the USA mean that a comprehensive development programme must be designed in order for the product to be commercialised in both regions.

The event has been designed to demonstrate how pharmaceutical, pharmacological, toxicological and clinical investigations and regulatory management are brought together in the development programme. It will take participants through all the stages in the development of a veterinary medicinal product for which a marketing authorisation is sought in the EU and the USA. Presentations will cover pharmaceutical and process development, toxicological, pharmacological, residues and environmental studies, safety risk assessments, clinical development, regulatory and marketing input and project management.

Gain a comprehensive understanding of the processes for the EU and USA, including:

• EU and US regulatory frameworks, strategies and procedures 
• EU Maximum Residues Limits applications and consumer safety evaluation in the marketing authorisation
• US FDA approach to Human Food Safety studies
• User safety risk assessment 
• Environmental risk assessment 
• EU and US target animal safety
• Planning pre-clinical and clinical development
• Overview of the Chemistry Manufacturing and Controls package
• Limited Markets applications and Minor Use and Minor Species (MUMS)
• Writing and managing regulatory submissions