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.
Upcoming start dates
Suitability - Who should attend?
Benefits of attending
- Explore EU and US regulatory frameworks, strategies and procedures
- Learn the EU Maximum Residues Limits applications and consumer safety evaluation in the marketing authorisation
- Understand US FDA approach to Human Food Safety studies
- Clarify user safety risk assessment and environmental risk assessment
- Know EU and US target animal safety
- Plan pre-clinical and clinical development
- Gain an overview of the Chemistry Manufacturing and Controls package
- Look at limited Markets applications and Minor Use and Minor Species (MUMS)
- Grasp writing and managing regulatory submissions
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Reviews by course attendees
Average rating 4.5
The programme is very complete as it is and nicely balanced with workshop and presentation […] All three were very nice and clear speakers with good atmosphere.
There was a good level of information provided and some good real examples added that made it easier to understand. The speakers were clearly knowledgeable and able to share kno...
About IPI Academy
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...
Very clear and complete presentation. Very experimented speakers