Five Day European Union and USA Veterinary Medicine Development Online Training Course, June 21-25, 2021
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:
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.
Key Topics Covered:
Day 1 09:00 - 15:00 UK/London
EU regulatory framework for regulation of veterinary medicines
What is the EU?
EU legal framework for regulation of veterinary medicines
Legal base of procedures and data requirements
US regulatory framework for regulation of veterinary drugs
Current governing laws and regulations
Federal agency jurisdictions
EU and USA: differences and similarities
INAD and NAD in the USA
Phased submission in USA vs marketing authorisation application in EU
EU MRLs vs US HFS section
EU renewal, variations, extensions vs US supplements
EU certificate of suitability and EDMFs vs US DMFs
Different requirements for user safety and environmental risk assessments
The global development programmes
Requirements for EU
Requirements for the USA
Achieving a global development programme
USA regulatory strategies and procedures
Applications for NCEs and supplements
Generic drug applications
EU regulatory strategies and procedures
Full and abbreviated applications
Generic applications
Centralised procedure
Decentralised, MRP and national procedures
Day 2 09:00 - 15:15 UK/London
MRLs Part A safety and MAA Part IIIA
The toxicological data requirements
Determining the NOEL and ADI
USA FDA approach to HFS studies
Toxicology studies
Margins of safety
MRLs Part B residues and MAA Part IIIB
'Hot' and 'cold' residue studies
How to determine maximum residue limits
Analytical methods for residues
Determining the withdrawal period
FDA evaluation of consumer safety
Human food technical safety section
Residue issues
Workshop - session 1
Day 3 09:00 - 14:45 UK/London
Environmental risk assessment Phases I and II
Critical evaluation of your data package
Phase I assessment
Refining risk assessment
Phase II assessment Tiers A and B
What to do if risk assessment gives cause for concern
User safety risk assessment in the EU
Reviewing toxicology studies
Setting the scenario
Risk assessment and management
Pharmacokinetics and bioequivalence
ADME studies
Bioequivalence
Workshop - session 2
Day 4 09:00 - 14:45 UK/London
EU and US clinical development
Dose selection
Field studies
VICH guidelines
Claim-driven approach in the US
Protocol review and concurrence with CVM
Value of VICH guidance
EU and US target animal safety
Pivotal target animal safety studies
Filed safety studies
New VICH guideline on TAS
Minor use and minor species (MUMS)
MUMS approaches in EU and USA
What are minor uses?
What are minor species?
Approaches to preparation of clinical data
Workshop - session 3
Day 5 09:00 - 14:45 UK/London
Workshop - presentations
Pharmaceutical development and the CMC package
Characterising the active substance
Formulation development
Analytical development and setting specifications
Process scale-up and validation
Stability studies and shelf life
Managing the USA regulatory submission
Systems of review at CVM
Team interaction
Company and regulator interactions
Writing and managing the EU regulatory submission
Writing the marketing authorisation application
Summary of product characteristics and labelling
Working with writers on detailed and critical summaries in the EU
Pre-submission advice and oral hearings
For more information about this conference visit https://www.researchandmarkets.com/r/scktqz
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