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

This course provides a comprehensive understanding of how to develop a veterinary medicine in the EU and USA. Different approaches taken by the regulatory authorities in the European Union and the USA mean that a comprehensive development programme must be designed in order for the product to be commercialised in both the American and European regions.

This course 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 the participants through all the stages in the development of a veterinary medicinal product for which a marketing authorisation is sought in the European Union and the USA.

An important part of the course will be devoted to working on case studies in the workshop sessions. The course will provide a comprehensive introduction to the entire development programme.

• Anyone with limited experience in only one of the disciplines in veterinary medicine development, such as:
  • Pharmaceutical or analytical development
  • Clinical trials
  • Regulatory affairs
  • Quality assurance
• Anyone learning the role of project manager
• Experienced personnel seeking to review special problems in product development
• Previous delegates include:
  • Clinical and pharmaceutical scientists
  • Regulatory affairs
  • R&D
  • Marketing managers

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

• EU and US regulatory frameworks, strategies and procedures
• MRLs Parts A & B; MAA Parts IIIA & IIIB
• US FDA approach to HFS Studies
• User safety risk assessment in the EU
• Planning pre-clinical and clinical development
• Environmental risk assessment phases I and II
• EU and US target animal safety
• Minor Use and Minor Species (MUMS)
• Writing and managing regulatory submissions