DUBLIN–(BUSINESS WIRE)–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/ozhof0
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
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
Related
Topics: Animal
Healthcare/Veterinary, Animal
Pharmaceuticals