4-Day Course - How to Develop Veterinary Medicine in the EU and USA (London, UK - June 8th-11th, 2020)

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Mar 03, 2020, 07:00 ET

DUBLIN, March 3, 2020 /PRNewswire/ -- The "Working Through Veterinary Drug Development in the EU and USA" conference has been added to ResearchAndMarkets.com's offering.

This intensive four-day course provides a thorough understanding of how to develop veterinary medicine in the EU and USA.

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

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

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.

An important part of the programme will be devoted to working on case studies to help consolidate knowledge. Please bring a laptop with you for use during these workshop sessions.

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/vlkaeb

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SOURCE Research and Markets