Presented by
Management Forum
The Animal Health Summer School: Working Through Veterinary Drug Development in the EU (European Union) and USA Training Course
This practical four-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.
★★★★★ "I was hoping to learn about the reg process for companion animals - the course more than delivered o... more (26)"
16-19 June 2025 »
from £1999
- Format: Classroom
- CPD: 24 hours for your records
- Certificate of completion
- Veterinary Pharmaceutical Submissions in the EU
- A Practical Approach to Veterinary Vaccine Development and Registration in the EU
- The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA
- Practical Implementation of GCP in Veterinary Field Studies
- A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products
- Registration of Veterinary Pharmaceuticals in China
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.
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.
Benefits of attending
- Explore EU and US regulatory frameworks, strategies and procedures
- Learn the EU Maximum Residues Limits applications and consumer safety evaluation in the marketing authorisation
- Understand US FDA approach to Human Food Safety studies
- Clarify user safety risk assessment and environmental risk assessment
- Know EU and US target animal safety
- Plan pre-clinical and clinical development
- Gain an overview of the Chemistry Manufacturing and Controls package
- Look at limited Markets applications and Minor Use and Minor Species (MUMS)
- Grasp 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.
This 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
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.
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.
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
16-19 June 2025
Summer school
Classroom
Rembrandt Hotel
London
09:00-17:30 UK (London)
Course code 14755
Optional £290/€404/$462 per night
- GBP 1,999 2,399
- EUR 2,799 3,359
- USD 3,119 3,743
Until 12 May
- 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
Not ready to book yet?
for 7 days, no obligation
* 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.
Reviews of IPI's The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA training course
I was hoping to learn about the reg process for companion animals - the course more than delivered on this!
Jun 17 2024
Scott J. Roberts 
Reader in Translational Skeletal Research, Royal Veterinary College
Jun 17 2024
Nice training with committed speakers, participants were involved. Content is dense but well explained.
Anne Trotel 
Clinical Project Manager, Ceva Animal Health
Jun 19 2023
Very clear and complete presentation. Very experimented speakers
Florian Lamarque
Planificateur, Ceva Santé Animale
Sep 12 2022
The programme is very complete as it is and nicely balanced with workshop and presentation […] All three were very nice and clear speakers with good atmosphere.
Clélia Stevenin
Regulatory Affairs Manager, Boehringer Ingelheim France
Sep 12 2022
There was a good level of information provided and some good real examples added that made it easier to understand. The speakers were clearly knowledgeable and able to share knowledge
Angela Thornton
Dechra Pharmaceuticals plc
Jun 21 2021
The webinar was prepared in a high quality manner.
Michel Salatiel Guzman Gomez 
Boehringer Ingelheim Vetmedica GmbH
Jun 3 2019
David and Julian explained the overall process clearly and concisely, highlighting challenges and proposing solutions to encourage smooth transitions throughout the development process and registration in the EU and US. The course was very interactive and I enjoyed the case study – working through the development process with other industry colleagues, and listening to their approaches for their cases. It was great to have resources easily accessible, and the expertise of [the speakers] to allow for open discussions.
Abigail Harwood 
Regional Pharmacovigilance Coordinator, Bayer
Jun 3 2019
Clear, concise content. Very knowledgeable speakers that we open to questions and discussion throughout the course.
Gemma Kennedy 
Head of Regulatory & Quality, TriviumVet
Jun 3 2019
Speakers were very knowledgable on the subject matter.
Rondeep Bhui
Director, Global Pharmacovigilance, Elanco Animal Health
Jun 3 2019
An excellent comprehensive course that helps bridge both the EU and USA regulatory realities. Very professional and competent speakers. Masterclass level, definitely a must for those starting in project development!
Adrienne Frasco Schellauf 
Regulatory Affairs Senior Associate, Zoetis
Jun 3 2019
Both [the speakers] did a really good Job
Daniel Kulke
Head of Laboratory, Bayer Animal Health GmbH
Jun 5 2017
Excellent - kept dry subject matter interesting and interactive. Well planned and excellent speakers with lots of real life experience
Melissa Coffman 
Clinical Manager, Ceva Animal Health
Jun 5 2017
Really good, I would recommend it
Daniel Rodes
Merial SAS
Jun 5 2017
The course was put together very well in its entirety - location, accommodations, course length and content, speakers
Jean Dory
Manager, Dechra Development
Jun 5 2017
Extremely professional, could not find better qualified speakers. Definitely a masterclass
Ludovic Pelligand
Associate Professor in Clinical Pharmacology and Anaesthesia, Royal Veterinary College
Jun 5 2017
Overall it was very good course
Pinalee Nanda
Regulatory Affairs Specialist, Bayer New Zealand Ltd
Jun 5 2017
Very well organised. Great venue. Well planned, interesting content.
Rich Irvine
Veterinary Surgeon, Carus Animal Health Limited
Jun 6 2016
Great speakers, great quality of the talks, great discussions, perfect operations team, feel-good atmosphere
Claudia Boehm
Veterinarian - Head of Laboratory, Bayer Animal Health GmbH
Jun 6 2016
Excellent choice of subjects covering the area indicated in the title of the course. I appreciate very much the presence of (almost) all speakers during all of the lectures, which enabled questions and discussions. Individual lectures complemented one another favourably without unnecessary duplication, which indicated cooperation of speakers in the preparation of the entire course.
Magdalena Dettwiler 
Safety Manager, Senior Research Scientist, Elanco Animal Health
Jun 6 2016
Very interesting course, enriching, speakers know a lot what they are talking about and can answer all questions. Really good!
Marine Porri
Project Formulation Manager, Ceva Sante Animale Sa
Jun 6 2016
Pretty good, lot of information and workshop session is very important!
Aurelie Lopez
Data Management and Biostatistics Manager, CEVA Sante Animale
Jun 6 2016
The course provided a fantastic learning experience. The course materials were varied, so that everyone was able to learn something. The speakers are quite knowledgeable, and encouraged questions. It was easy to see that they actually wanted us to learn, and that goes a long way. The course was well organized, and I really enjoyed the out of class activities, specifically the theater trip. Overall, a really great learning experience and I would highly recommend it to anyone.
Kelsey Biegun
Regulatory Affairs Officer, Dechra Ltd
Jun 6 2016
Very interesting course, enriching, speakers know a lot what they are talking about and can answer all questions. Really good!
Marine Porri
Project Formulation Manager, Ceva Sante Animale Sa
Jun 6 2016
The course was really good content. All the speakers had vast knowledge on the subjects and were happy to answer any questions.
Susan Scanlan
Principal Scientist, Dechra Limited
Jun 6 2016
Very interesting course, enriching, speakers know a lot what they are talking about and can answer all questions. Really good!
Marine Porri
Project Formulation Manager, Ceva Sante Animale Sa
Jun 6 2016
Very good, easy to understand
Naomi Isaka
Live Stock Clinical Development Manager, CEVA Sante Animale
United Kingdom
- Benchmark Animal Health
- Benchmark Animal Health Ltd
- Carus Animal Health Limited
- Colamussi & Deacon Veterinary Services LTD
- Cyton Biosciences Ltd
- Cyton Biosciences Ltd.
- Dechra Limited
- Dechra Ltd
- Dechra Pharmaceuticals plc
- Eco Animal Health Ltd
- Elanco Animal Health
- Norbrook Laboratories Ltd
- Novartis Animal Health UK Ltd
- Royal Veterinary College
- Veterinary Medicines Directorate
Germany
- Bayer Animal Health GmbH
- Bela-Pharm GmbH & Co. KG
- BI Vetmedica GmbH
- Boehringer Ingelheim
- Boehringer Ingelheim Animal Health GmbH
- Boehringer Ingelheim Pharma GmbH & Co KG
- Boehringer Ingelheim Vetmedica GmbH
- GAB Consulting GmbH
- MSD Animal Health Innovation GmbH
- Nordmark Pharma GmbH
United States of America
- Boehringer Ingelheim Vetmedica - Inc. BIVI
- Boehringer-Ingelheim Animal Health
- Ceva Animal Health
- Dechra
- Dechra Development
- Dechra Ltd
- Merck Animal Health
- Merial
- Novartis Animal Health US Inc
France
- Boehringer Ingelheim France
- Ceva Animal Health
- CEVA Sante Animale
- Ceva Sante Animale Sa
- Elanco
- Merial
- Merial SAS
- MSD Animal Health Innovation
Switzerland
- Elanco Animal Health
- EPITERNA
- F. Hoffmann-La Roche Ltd
- Novartis Animal Health Inc
- Swissmedic
Japan
- Bussan Animal Health
- Mitsui & Co UK plc
- Sumitomo Chemical
- Sumitomo Chemical Co Ltd.
Belgium
- IFAH - Europe
- Zoetis
Finland
- Orion Corp. Orion Pharma
- Orion Corporation
Netherlands
- Dechra Limited
- Dechra Pharmaceuticals
New Zealand
- Bayer
- Bayer New Zealand Ltd
Norway
- PHARMAQ
- Pharmaq AS
Argentina
- Brouwer S.A.
China
- Boehringer Ingelheim Animal Health (Shanghai) Ltd
Croatia
- Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Denmark
- Boehringer-Ingelheim Danmark A/S
Egypt
- Zoetis
Hungary
- Boehringer Ingelheim RCV GmbH & Co KG
Ireland
- TriviumVet
Portugal
- Hifarmax, Produtos e Serviços Veterinários, Lda.
Spain
- Novus Spain SA
Turkey
- Sanofi-Aventis Turkey
Uganda
- National Drug Authority
Run The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA Classroom for your team
5 days
Typical duration
Pricing from:
- GBP 1,500
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
