Description
he course will provide a comprehensive introduction to the entire development programme for companion animal medicines. 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 their responsibilities to the expertise and needs of the scientists and commercial members of the team.
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 of the stages in the development of a veterinary medicinal product for companion animals, for which a marketing authorisation is sought in the European Union. Presentations will cover pharmaceutical and process development, toxicological, pharmacological, safety risk assessments, clinical development and regulatory submissions. An important part of the course will be devoted to working on case studies in the workshop sessions.
