This course provides a comprehensive 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 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. 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.
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.
WHY YOU SHOULD ATTEND
THREE REASONS TO ATTEND
- Gain a comprehensive understanding of the entire development programme of a veterinary medicine
- Understood regulatory differences between the EU and USA
- Put in practice what you learn via several workshops
WHO SHOULD ATTEND
This course has been designed for anyone who has limited experience in only one of the disciplines in veterinary medicine development, such as pharmaceutical or analytical development, clinical trials, regulatory affairs or quality assurance. Anyone learning the role of project manager, as well as more experienced personnel seeking to review special problems encountered in product development, will benefit from the comprehensive programme delivered by experienced professionals. Previous delegates who have benefited from this course include Clinical Scientists, Pharmaceutical Scientists and Regulatory Affairs, R & D, Development and Marketing Managers. There will be ample opportunity for information discussion during the proceedings.
|Building:||The Rembrandt Hotel|
|Address:||11 Thurloe Place|
|Type:||Course & Training|