About this Course
*This is a Residential Course - the registration fee includes four nights’ accommodation and all meals. A non-residential fee is available on request.
25% Discount for members of the Animal Health Institute, USA
Benefits in Attending the Animal Health Autumn School:
- Gain a comprehensive overview of the entire development process
- Understand the EU and US regulatory framework
- Achieve successful submission of your veterinary medicine
- Define the differences between the EU and US approach to the development of a veterinary product
- Share knowledge and experiences with other delegates and speakers from the EU and US
- Gain practical hands on experience working on case studies within the workshop sessions
INTRODUCTION AND OBJECTIVES
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. 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 ecotoxicological studies, safety risk assessments, clinical development, pharmacovigilance, 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.
Members of AHI, USA will receive a 25% discount off the registration fee. Please quote AHI09 when registering to receive the offered discount.
About Management Forum
Management Forum has had a portfolio of Life Science events running since 1983. We are at the cutting edge of information exchange, organising over 250 conferences, seminars and residential schools every year. All of our events are researched by our experienced course directors and designed to help you make informed decisions and remain up to date with 'need to know' business information.
Management Forum Conferences offer you the opportunity to network with colleagues in your area of business and our Seminars and Residential Schools provide an intimate, interactive environment in which to learn about the latest techniques and developments.
Take advantage of the whole range of Management Forum products to help you keep up-to-date on the latest developments within Pharmaceutical and associated industry sectors.
Management Forum’s Animal Health events schedule is designed to provide a unique educational platform to understand the regulatory, clinical and pharmacovigilance requirements, and to discover best practices for the development of veterinary pharmaceutical and biological medicines.
