Five Day European Union and USA Veterinary Medicine

Dublin, June 11, 2021 (GLOBE NEWSWIRE) – The conference “Working Through Veterinary Drug Development in the EU (European Union) and USA Training Course” has been added to ResearchAndMarkets.com to offer.

This five-day intensive course provides a thorough understanding of the development of a veterinary medicinal product in the EU and the US.

The development of veterinary medicine is complex, time consuming and expensive. It requires teamwork from individuals with diverse academic backgrounds and a wide range of skills.

All those involved must know the essential phases of the development program and be able to relate their responsibility to the skills and needs of the scientists and commercial members of the team.

In addition, different approaches by regulators in the EU and the US require a comprehensive development program in order to be able to commercialize the product in both regions.

The event aims to demonstrate how pharmaceutical, pharmacological, toxicological and clinical trials as well as regulatory management are brought together in the development program. It guides participants through all phases of the development of a veterinary medicinal product for which authorization is sought in the EU and the USA.

Presentations include pharmaceutical and process development, toxicological, pharmacological, residue and environmental studies, safety risk assessments, clinical development, regulatory and marketing contributions and project management.

Gain a thorough understanding of the EU and US processes including:

• EU and US regulatory framework, strategies and procedures n MRLs parts A and B; MAA parts IIIA & IIIB
• US FDA Approach to HFS Studies
• User Safety Risk Assessment in the EU
• Planning of preclinical 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 submission submission applications

Who should attend:

This course is for anyone with limited experience in only one of the disciplines of veterinary development, such as: B. pharmaceutical or analytical development, clinical studies, regulatory affairs or quality assurance. Everyone who learns the role of project manager, as well as more experienced employees who want to deal with specific problems in product development, benefit from the comprehensive program of experienced professionals.

Past delegates who have benefited from this course include clinical scientists, pharmaceutical scientists, marketing managers, and regulatory, research and development, and development staff.

Key topics covered:

Day 1 9:00 am – 3:00 pm UK / London

EU legal framework for the regulation of veterinary medicinal products

• What is the EU?
• EU legal framework for the regulation of veterinary medicinal products
• Legal basis of the procedures and data requirements

US regulatory framework for the regulation of veterinary drugs

• Current applicable laws and regulations
• Responsibilities of the federal authorities

EU and USA: Differences and Similarities

• INAD and NAD in the US
• Staggered filing in the US vs. application for approval in the EU
• Section EU MRLs vs. US HFS
• EU renewals, changes, extensions vs. US additions
• EU suitability certificate and EDMFs vs. US DMFs
• Different requirements for user safety and environmental risk assessments

The global development programs

• Requirements for EU
• Requirements for the USA
• Achieve a global development program

US regulatory strategies and procedures

• Requests for NCEs and supplements
• Generic applications

EU regulatory strategies and procedures

• Complete and abridged applications
• Generic applications
• Centralized procedure
• Decentralized, MRP and national procedures

Day 2 9:00 am – 3:15 pm UK / London

MRLs Part A Safety and MAA Part IIIA

• The toxicological data requirements
• Determination of NOEL and ADI

US FDA Approach to HFS Studies

• Toxicological Studies
• Safety margins

Maximum residue levels Part B and MAA Part IIIB

• “Hot” and “Cold” residue studies
• How to determine maximum residue levels
• Analysis methods for residues
• Determination of the withdrawal period

FDA Consumer Safety Assessment

• Section on the technical safety of food for humans
• Backlog problems

Workshop – session 1

Day 3 9:00 am – 2:45 pm UK / London

Environmental risk assessment phases I and II

• Critical evaluation of your data package
• Phase I evaluation
• Refinement of the risk assessment
• Phase II assessment of levels A and B
• What to do if the risk assessment gives cause for concern

User Safety Risk Assessment in the EU

• Review of toxicological studies
• Set the scenario
• Risk assessment and management

Pharmacokinetics and Bioequivalence

• ADME studies
• Bioequivalence

Workshop – session 2

Day 4 9:00 am – 2:45 pm UK / London

Clinical development in the EU and the USA

• Dose selection
• field research
• VICH guidelines
• Claim-driven approach in the USA
• Protocol review and compliance with CVM
• Value of the VICH leadership

EU and US target animal safety

• Central Target Animal Safety Studies
• Submitted security studies
• New VICH directive on TAS

Minor Use and Minor Species (MUMS)

• MUMS approaches in the EU and USA
• What are minor uses?
• What are minor species?
• Approaches to the preparation of clinical data

Workshop – session 3

Day 5 9:00 am – 2:45 pm UK / London

Workshop presentations

Pharmaceutical Development and the CMC Package

• Characterization of the active ingredient
• Formulation development
• Analytical development and specification of specifications
• Process scale-up and validation
• Stability studies and shelf life

Administration of regulatory filings in the United States

• Verification systems at CVM
• Team interaction
• Interactions between companies and regulators

Writing and managing the EU authorization application

• Writing the application for admission
• Summary of product features and labeling
• Collaboration with authors on detailed and critical summaries in the EU
• Pre-filing advice and oral hearings

For more information on this conference, please visit https://www.researchandmarkets.com/r/scktqz