Dublin, April 30, 2019 (GLOBE NEWSWIRE) -- The "Working Through Veterinary Drug Development in the EU and USA" conference has been added to ResearchAndMarkets.com's offering.

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 programme will be devoted to working on case studies in the workshop sessions.

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

• EU and US regulatory frameworks, strategies and procedures n 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 n EU and US target animal safety
• Minor use and minor species (MUMS)
• Writing and managing regulatory submissions

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, marketing managers and personnel from regulatory affairs, R&D and development.

Agenda:

Day 1

• Introduction and objectives of course
• EU regulatory framework for regulation of veterinary medicines
• US regulatory framework for regulation of veterinary drugs
• EU and USA: differences and similarities
• The global development programmes
• USA regulatory strategies and procedures
• EU regulatory strategies and procedures
• Introduction to workshop - session 1

Day 2

• MRLs Part A safety and MAA Part IIIA
• USA FDA approach to HFS studies
• MRLs Part B residues and MAA Part IIIB
• FDA evaluation of consumer safety
• Environmental risk assessment Phases I and II
• User safety risk assessment in the EU
• Workshop session 2

Day 3

• Pharmacokinetics and bioequivalence
• EU and US clinical development
• EU and US clinical development (continued)
• EU and US target animal safety
• Minor use and minor species (MUMS)
• Workshop session 3

Day 4

• Workshop presentations
• Pharmaceutical development and the CMC package
• Managing the USA regulatory submission
• Writing and managing the EU regulatory submission
• Closing remarks

For more information about this conference visit https://www.researchandmarkets.com/r/6fjgz5

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Related Topics: Animal Healthcare/Veterinary, Animal Pharmaceuticals 

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