|Five Day European Union and USA Veterinary Medicine Development Online Training Course, June 21-25, 2021|
|By GLOBE NEWSWIRE|
|Thursday, 10 June 2021 23:08|
Dublin, June 11, 2021 (GLOBE NEWSWIRE)
Dublin, June 11, 2021 (GLOBE NEWSWIRE) -- The "Working Through Veterinary Drug Development in the EU (European Union) and USA Training Course" conference has been added to ResearchAndMarkets.com's offering.
This intensive five-day course provides a thorough understanding of how to develop a veterinary medicine in the EU and USA.
The development of 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 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.
Gain a comprehensive understanding of the processes for the EU and USA, including:
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.
Key Topics Covered:
Day 1 09:00 - 15:00 UK/London
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
Day 2 09:00 - 15:15 UK/London
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
Workshop - session 1
Day 3 09:00 - 14:45 UK/London
Environmental risk assessment Phases I and II
User safety risk assessment in the EU
Pharmacokinetics and bioequivalence
Workshop - session 2
Day 4 09:00 - 14:45 UK/London
EU and US clinical development
EU and US target animal safety
Minor use and minor species (MUMS)
Workshop - session 3
Day 5 09:00 - 14:45 UK/London
Workshop - presentations
Pharmaceutical development and the CMC package
Managing the USA regulatory submission
Writing and managing the EU regulatory submission
For more information about this conference visit https://www.researchandmarkets.com/r/scktqz
CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900