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Working Through Veterinary Drug Development in the EU (European Union) and USA Training Course

This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.

★★★★★ "The programme is very complete as it is and nicely balanced with workshop and presentation […] All t... more"

19-22 Jun 2023

Need help?  Enrol or reserve

  • Format: Classroom
  • CPD: 24 hours for your records
  • Certificate of completion

Course overview

This intensive five-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 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.

Enrol or reserve

The 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

  • INAD and NAD in 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 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

Workshop - session 1

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

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

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
  • 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

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

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.

More details

Andrew Hewitt

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.

More details

Book Working Through Veterinary Drug Development in the EU and USA Classroom training

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

19-22 Jun 2023

Classroom
London venue TBC

09:00-17:30 UK (London)
Course code 12806

  • GBP 1,999 2,399
  • EUR 2,799 3,359
  • USD 3,119 3,743

Until 15 May

  • 4 days classroom-based training
  • 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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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.

Reviews of IPI's Working Through Veterinary Drug Development in the EU and USA training course


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.

Sep 12 2022

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
Regulatory Affairs Manager, 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

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
  • 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

France

  • Boehringer Ingelheim France
  • Ceva Animal Health
  • CEVA Sante Animale
  • Ceva Sante Animale Sa
  • Elanco
  • Merial
  • Merial SAS
  • MSD Animal Health Innovation

Germany

  • Bayer Animal Health GmbH
  • Bela-Pharm GmbH & Co. KG
  • BI Vetmedica GmbH
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Pharma GmbH & Co KG
  • Boehringer Ingelheim Vetmedica GmbH
  • GAB Consulting GmbH
  • MSD Animal Health Innovation GmbH

United States of America

  • Boehringer Ingelheim Vetmedica - Inc. BIVI
  • Boehringer-Ingelheim Animal Health
  • Ceva Animal Health
  • Dechra
  • Dechra Development
  • Dechra Ltd
  • Merial
  • Novartis Animal Health US Inc

Switzerland

  • Elanco Animal Health
  • EPITERNA
  • F. Hoffmann-La Roche Ltd
  • Novartis Animal Health Inc

Belgium

  • IFAH - Europe
  • Zoetis

Japan

  • Sumitomo Chemical
  • Sumitomo Chemical Co Ltd.

New Zealand

  • Bayer
  • Bayer New Zealand Ltd

Norway

  • PHARMAQ
  • Pharmaq AS

Argentina

  • Brouwer S.A.

China

  • Boehringer Ingelheim Animal Health (Shanghai) Ltd

Denmark

  • Boehringer-Ingelheim Danmark A/S

Egypt

  • Zoetis

Finland

  • Orion Corporation

Hungary

  • Boehringer Ingelheim RCV GmbH & Co KG

Ireland

  • TriviumVet

Netherlands

  • Dechra Pharmaceuticals

Portugal

  • Hifarmax, Produtos e Serviços Veterinários, Lda.

Spain

  • Novus Spain SA

Turkey

  • Sanofi-Aventis Turkey

Uganda

  • National Drug Authority

Enrol or reserve

Run 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
  • 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 expert Aleksandra Beer to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy