Online training during Covid restrictions - our programes continue this spring in online webinar format

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.

7-10 Jun 2021

Book now


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 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

An important part of the programme will be devoted to working on case studies to help consolidate knowledge. Please bring a laptop with you for use during these workshop sessions.

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.

Programme – day one

Day 1

Introduction and objectives of course

EU regulatory framework for regulation of veterinary medicines

US regulatory framework for regulation of veterinary drugs

EU and USA: differences and similarities

The global development programmes

USA regulatory strategies and procedures

EU regulatory strategies and procedures

Introduction to workshop – session 1

Programme – day two

Day 2

MRLs Part A safety and MAA Part IIIA

USA FDA approach to HFS studies

MRLs Part B residues and MAA Part IIIB

FDA evaluation of consumer safety

Environmental risk assessment Phases I and II

User safety risk assessment in the EU

Workshop session 2

Programme day three

Day 3

Pharmacokinetics and bioequivalence

EU and US clinical development

EU and US clinical development (continued)

EU and US target animal safety

Minor use and minor species (MUMS)

Workshop session 3

Programme – day four

Day 4

Workshop presentations

Pharmaceutical development and the CMC package

Managing the USA regulatory submission

Writing and managing the EU regulatory submission

Closing remarks


Julian Braidwood (More...)

Dr Julian Braidwood qualified as a Veterinary Surgeon and worked in mixed practices before spending fifteen years in R&D and Regulatory departments of five leading Animal Health companies. He has managed clinical trials and regulatory groups, experimental facilities, laboratories, and worked internationally in many countries. Having become an R&D Director within the industry, he formed Triveritas in 2000 which has grown rapidly throughout Europe and North America and has offices in UK, France, Germany, Poland and USA. Triveritas provides specialist contract services to Animal Health and related companies. Triveritas develops veterinary vaccines and medicines by providing comprehensive services in veterinary regulatory affairs, regulatory maintenance, international clinical trials, QA, project/study management, and training. A tailored start to finish service takes client projects from proof of concept through to multi-national registrations.

David Petrick (More...)

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.

Book now

Book now

7-10 Jun 2021
Face-to-face, (venue not yet confirmed)
7-10 Jun 2021
(venue not yet confirmed)
GBP 2,399 1,999
EUR 3,359 2,799
USD 3,742 3,118
Until 26 Apr*
Enrol now
to attend
(venue not yet confirmed)
  • 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

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 24 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

You may also be interested in

Previous customers include...

  • Bayer Animal Health GmbH
  • Bayer Animal Health GmbH
  • Bayer New Zealand Ltd
  • Bela-Pharm GmbH & Co. KG
  • BI Vetmedica GmbH
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Pharma GmbH & Co KG
  • Boehringer Ingelheim RCV GmbH & Co KG
  • Boehringer Ingelheim Vetmedica - Inc. BIVI
  • Boehringer Ingelheim Vetmedica GmbH
  • Brouwer S.A.
  • Dechra
  • Dechra Development
  • Dechra Ltd
  • Eco Animal Health Ltd
  • Elanco Animal Health
  • GAB Consulting GmbH
  • IFAH - Europe
  • Merial
  • MSD Animal Health Innovation
  • MSD Animal Health Innovation GmbH
  • National Drug Authority
  • Norbrook Laboratories Ltd
  • Novartis Animal Health UK Ltd
  • Pharmaq AS
  • Sumitomo Chemical
  • Sumitomo Chemical Co Ltd.
  • TriviumVet
  • Veterinary Medicines Directorate
  • Zoetis

Both [the speakers] did a really good Job

Daniel Kulke, Head of Laboratory, Bayer Animal Health GmbH, Jun 19

Clear, concise content. Very knowledgeable speakers that we open to questions and discussion throughout the course.

Gemma Kennedy, Head of Regulatory & Quality, TriviumVet, Jun 19

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 19

Speakers were very knowledgable on the subject matter.

Rondeep Bhui, Director, Global Pharmacovigilance, Elanco Animal Health, Jun 19

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 19

Extremely professional, could not find better qualified speakers. Definitely a masterclass

Ludovic Pelligand, Associate Professor in Clinical Pharmacology and Anaesthesia, Royal Veterinary College, Jun 17

The course was put together very well in its entirety - location, accommodations, course length and content, speakers

Jean Dory, Manager, Dechra Development, Jun 17

Very well organised. Great venue. Well planned, interesting content.

Rich Irvine, Veterinary Surgeon, Carus Animal Health Limited, Jun 17

Really good, I would recommend it

Daniel Rodes, Merial SAS, Jun 17

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 17

Overall it was very good course

Pinalee Nanda, Regulatory Affairs Specialist, Bayer New Zealand Ltd, Jun 17

Very good, easy to understand

Naomi Isaka, Live Stock Clinical Development Manager, CEVA Sante Animale, Jun 16

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 16

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 16

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 16