Course overview

This intensive four-day course provides a thorough 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 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 a 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
EU Maximum Residues Limits applications and consumer safety evaluation in the marketing authorisation
US FDA approach to Human Food Safety studies
User safety risk assessment
Environmental risk assessment
EU and US target animal safety
Planning pre-clinical and clinical development
Overview of the Chemistry Manufacturing and Controls package
Limited Markets applications and Minor Use and Minor Species (MUMS)
Writing and managing regulatory submissions

This course forms part of our selection of Animal Health training courses, designed to keep you up to date with the latest regulations surrounding veterinary medicines, animal feeds, and industry best practices.

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.

Enrol or reserve

The The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA course will cover:

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

Phased submission in USA vs marketing authorisation application in EU
EU Maximum Residues Limits vs US Human Food Safety section
EU variations vs US supplements
EU Certificate of Suitability and Active Substance Master Files vs US Drug Master Files
Different requirements for user safety and environmental risk assessments

The global development programmes

Requirements for EU
Requirements for USA
Achieving a global development programme

USA regulatory strategies and procedures

Applications for New Animal Drug Applications and supplements
Generic drug applications

EU regulatory strategies and procedures

Full and abbreviated applications
Centralised procedure, Decentralised, Mutual/Subsequent Recognition and National procedures

Workshop - session 1

Safety dossier of the EU Maximum Residue Limits application

The toxicological data requirements
Determining the NOEL and ADI

USA FDA approach to Human Food Safety studies

Toxicology studies
Margins of safety

Residues dossier requirements in EU

‘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

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

Reviewing toxicology studies
Setting the scenario
Risk assessment and management

Workshop - session 2

Pharmacokinetics and bioequivalence

ADME studies
Bioequivalence

EU and US clinical development

Dose selection
Field studies
VICH guidelines
Claim-driven approach in US
Protocol review and concurrence with CVM
Value of VICH guidance

EU and US target animal safety

Pivotal target animal safety studies
Other safety studies

Limited Markets and 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

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

Enrol or reserve

David Petrick
The Delta Consortium, Regulatory Consulting Limited

Dr David Petrick has over 30 years’ experience in bringing novel animal health products to the marketplace. During his professional career he has worked in Regulatory Affairs and Product Development for both American Cyanamid Company and Schering-Plough Animal Health.
In 2004 he founded the Delta Consortium Regulatory Consulting Limited, serving as a consultant in Regulatory Affairs for animal health companies. In 2009 he joined Triveritas and was a part of the opening of Triveritas, USA. In 2004 Dr Petrick joined Velcera, a venture capital funded animal health company and was the Executive Vice President of Research Development and Regulatory Affairs. Velcera was sold to a major pharmaceutical company in 2010.
He holds a degree in veterinary medicine from the University of Pennsylvania, and a law degree from Seton Hall University. He is a member of the American Veterinary Medical Association, the American Bar Association, the New Jersey Bar Association and the New Jersey Bar.

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Andrew Hewitt
Knoell Animal Health

Dr Andrew Hewitt is a veterinarian with over 14 years of experience in Veterinary Medicinal Product development in a clinical and regulatory capacity. In his current position as Senior Advisor for Veterinary Product Development at knoell, Andrew manages all aspects of regulatory input in product development and registration, from early proof of concept right through to post authorisation work. Taking advantage of previous his previous role as a clinical practitioner in the UK, and investigator and monitor on clinical trials, Andrew brings a broad range of clinical and regulatory knowledge to projects. With extensive experience interacting with regulatory authorities in most major global animal health markets, Andrew has a particular interest in strategic regulatory planning during product development.

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NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

17-20 June 2024

Summer school

Classroom
Rembrandt Hotel
London

09:00-17:30 UK (London)
Course code 13742
Optional £270/€351/$405 per night

GBP 2,399
EUR 3,359
USD 3,743

Limited places remaining

4 days classroom-based training
Optional accommodation - 4 nights including breakfast, checking in the day before the course
Meet presenters and fellow attendees in person
Lunch and refreshments provided
Download documentation and certification of completion
Fair transfer and cancellation policy

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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.