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Management Forum

Veterinary Pharmaceutical Submissions in the EU (European Union) Training Course

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, critical expert reports and regulatory submissions.

★★★★★ "Very nice. I would recommend."

11-12 July 2024
+ 26-27 November 2024 »

from £1099

Need help?  Enrol or reserve

Course overview

Obtaining a marketing authorisation for a veterinary medicine can be a costly and time-consuming process and this practical two-day course will equip participants with the key information to achieve a successful application.

The programme will take delegates through all of the constituent parts of the application for marketing authorisation for a veterinary medicinal product in the European Union, including the maximum residue limits dossier.

Presentations will cover the regulatory framework; pharmaceutical, toxicological and pharmacological data; safety risk assessments; pre-clinical and clinical data; critical expert reports and regulatory submissions.

An important part of the programme will be devoted to working on case studies in the workshop sessions and there will be ample opportunity for discussion throughout the two days with the expert trainer and fellow professionals.

Benefits of attending:

  • Understand the EU regulatory framework
  • Learn the pharmaceutical data requirements
  • Know how to comply with the safety requirements
  • Review the user safety risk assessment
  • Consider the environmental risk assessment
  • Receive guidance on preparing critical expert report
  • Consider the pre-clinical and clinical requirements
  • Take away regulatory strategies and procedures
  • Acquire the skills to write the regulatory submission

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?

Personnel working in the following departments:

• Regulatory affairs
• Research and development
• Clinical trials
• Marketing

The course will also be valuable to those seeking to review special problems encountered in the registrations of veterinary medicines.

Enrol or reserve

The Veterinary Pharmaceutical Submissions in the EU course will cover:

EU regulatory framework

  • Understanding the regulatory objectives
  • EU legal framework
  • Legal base of regulatory procedures and dossier requirements

Part II: Pharmaceutical data requirements

  • Formulation and analytical data
  • Manufacturing process
  • Stability studies

Maximum Residue Limits (MRLs) - Safety and residue data requirements

  • MRL dossier: safety file (pharmacology and toxicological studies)
  • MRL dossier: residue file (metabolism and residue studies)

Pharmacokinetics and bioequivalence

Workshop session

Planning a dossier to contain:

  • Pharmaceutical development studies
  • Toxicological, pharmacokinetic, metabolism and residue studies
  • Pre-clinical and clinical studies

Part III of the marketing authorisation application

  • Pharmacology and toxicology studies
  • User safety risk assessment
  • Setting the scenario
  • Risk assessment and management
  • Environmental risk assessment
  • Phase I and II assessments
  • Residue depletion studies
  • Setting the withdrawal period

Part IV: Pre-clinical data

  • Pharmacodynamics and pharmacokinetics
  • Target species tolerance
  • Resistance

Part IV: Clinical data and clinical detailed and critical summaries

  • Clinical trials
  • Clinical detailed and critical summaries

EU regulatory strategies and procedures

  • Full and abbreviated applications
  • Generic applications
  • Centralised procedure
  • Decentralised, MRP and national procedures

Writing the regulatory submission

  • Writing the dossier
  • Summary of product characteristics and labelling
  • Working with writers of detailed and critical summaries

Enrol or reserve

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.

More details

Dave Parry
knoell Animal Health

David Parry is a chemist with over 14 years of experience in in veterinary medicinal product development and registration. In his current position as CMC team leader at knoell, David works with manufacturers in developing formulations and the commercial manufacturing process. Taking advantage of his previous roles in pharmaceutical research and development and process development, David brings a broad range of chemistry, manufacturing and regulatory knowledge to projects. With extensive experience interacting with regulatory authorities in most major global animal health markets and working with contract manufacturing organisations, David is involved with all aspects of regulatory support from early stage development through to post approval product maintenance.

More details

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

11-12 July 2024

Live online

09:00-16:30 UK (London) (UTC+01)
10:00-17:30 Paris (UTC+02)
04:00-11:30 New York (UTC-04)
Course code 13802

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 06 Jun

Online registration unavailable: this date is nearing full capacity; please contact us to register.

26-27 November 2024

Rembrandt Hotel

08:30-16:30 UK (London)
Course code 14095
Optional £240/€312/$360 per night

  • GBP 1,299 1,499
  • EUR 1,869 2,149
  • USD 2,137 2,449

Until 22 Oct

  • 2 days classroom-based training
  • Optional accommodation - 2 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

View basket 

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 Veterinary Pharmaceutical Submissions in the EU training course

Very nice. I would recommend.

Dec 12 2023

Magali Rigo
RA Pharma Manager, Boehringer Ingelheim Animal Health

Dec 12 2023

I wanted to get some good practices on how to manage dossier from a strategic and admin standpoint. Recommendations were given during the training so I think info I wanted to get was given.

Karine Tanan
Principal Scientist, Scientific and Regulatory Affairs, Cargill R and D Centre Europe

Mar 6 2023

Excellent presentation with very useful content and information. Great speakers with brilliant experience who were always available to respond any question.

Karen Vásquez Cruz
Regulatory Affairs Officer, Hygeia Chemicals Limited

Mar 6 2023

The overall opinion is that the webinar was great.

Johanna Axling
Product manager, FarmPharma

Dec 6 2021

[Particularly liked]: The speaker and his ability to share the information. The complex structure of the course. The workshop prepared for us

Daniel Pepa
Jr. Manager GRA Pharma Vetcare, B. Braun Melsungen AG

Dec 6 2021

I enjoyed the event and even through a virtual platform it was very personable. Overall very happy with the large volume of information provided. My aspirations from the meeting were met as I wanted an overall understanding of the regulations.

Brendan Moran
Technical Director, Hygeia

Dec 6 2021

the content was very useful to continue investigating further, the workshop was quite nice also

Karine Tanan
Principal Scientist, Scientific and Regulatory Affairs, Cargill R and D Centre Europe

Mar 3 2021

I was overall happy with the webinar. Julian was very clear and ready to answer any question throughout the webinar.

Veronica Nannetti
DVM Regulatory Department, Fatro Spa

Mar 3 2021

Great speaker, tremendous experience. I am extremely satisfied with the level of information and knowledge acquired throughout the last 2 days. I would definitely recommend this course and this format to all stakeholders approaching the Veterinary Pharmaceutical Submissions in the EU.

Alessio Giannelli
Regulatory Science Liaison, Inovet

Nov 18 2020

Very friendly speaker.

Edouard Timsit
chef de projet recherche - ruminant, CEVA SANTE ANIMAL

May 22 2019

A comprehensive course to understand the basis for the registration of animal medicines in EU. Great speaker, easy to listen to.

Ludovique Van Gastel
Scientific Writer, Galderma R&D

Nov 26 2019

This course teaches you the essentials of EU veterinary regulatory affairs and enables you to understand the different strategies and how to achieve a successful registration through the excellent content, presentation and speaker who knows to inspire you with his enthusiasm and easy-to-follow way of teaching. Thank you Julian!. I particularly liked the workshop, during which i learnt a lot.

Rachael Benjamin
Regulatory Affairs Officer, Beaphar B.V.

May 22 2019

The very complex theme was presented in an exciting, motivating and relaxed way. Connections were presented in a comprehensible way

Heike Luckow
Regulatory Affairs, Bela-Pharm GmbH & Co. KG

Nov 26 2019

Very interesting content and program, presented in a clear, pleasant and appealing way. The workshops were well prepared and very helpful and the speaker was always available to help with any questions.

Marlene Delgado

Apr 25 2018

Great speaker, easy to listen to. Good sense of humour.

Pauline Schipper
Associate Regulatory Affairs Manager, Zoetis B.V.

Apr 25 2018

I'm very satisfied with the course overall!

Renée Alberda
Supervisor Regulatory Affairs, Kepro B.V.

Apr 25 2018

Very nice presentation and all the 'real life' stories were of added value. Good interesting course with a very nice group.

Iris Visser
Regulatory Affairs Officer, Belgica De Weerd BV

Nov 28 2017

Excellent speaker

Sandra Lickova
Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG

Nov 28 2017

Excellent speaker with interesting and entertaining stories from his own experience.

Marie Lovoll
Research Director, VESO

Nov 28 2017

Brilliant speaker

Sandra Lickova
Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG

Dec 1 2016

The content, presentations and speaker was very good - and I got a whole lot out of it

Mads Thor Madsen
Medical Advisor, DVM, Jacobsen Pharma & MedTech Advice A/S

Dec 1 2016

Very good

Renate Makovska
Food & Veterinary Service

United Kingdom

  • Animalcare Ltd
  • Benchmark Animal Health
  • Benchmark Vaccines Ltd
  • British American Tobacco (Investments) Limited
  • Cyton Biosciences Ltd
  • Cyton Biosciences Ltd.
  • Danisco (UK) Limited
  • Dechra Ltd
  • Diamond BioPharm Ltd
  • DP Consulting
  • ECO Animal Health Limited
  • Eco Animal Health Ltd
  • Eli Lilly & Company Limited/Elanco Animal Health
  • Eli Lilly & Company Ltd
  • Iriska Ltd.
  • knoell Animal Health Ltd.
  • NOAH ltd
  • Norbrook Laboratories Ltd
  • Novartis Animal Health UK Ltd
  • Pfizer Limited
  • Veterinary Medicines Directorate
  • Vita (Europe) Ltd
  • VMD
  • Zoetis


  • aniMedica GmbH
  • B. Braun Melsungen AG
  • Bayer Animal Health GmbH
  • Bayer Pharma AG
  • Bela-Pharm GmbH & Co. KG
  • Boehringer Ingelheim
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Ltd
  • Boehringer Ingelheim Vetmedica GmbH
  • Dechra Veterinary Products Deutschland GmbH
  • Klifovet A.G.
  • MSD Animal Health Innovation GmbH


  • Boehringer Ingelheim
  • Boehringer Ingelheim Animal Health
  • Boehringer Ingelheim France
  • CEVA Sante Animale
  • Galderma R&D
  • Merial Business
  • Merial SAS
  • Sogeval Laboratories
  • Vetoquinol SA
  • Virbac Corporation


  • Avimedical BV
  • Beaphar B.V.
  • Belgica De Weerd BV
  • Dada Consultancy BV
  • Dopharma Research BV
  • Fort Dodge Animal Health
  • Interchemie werken De Adelaar BV
  • Kepro B.V.
  • Pharma Laboratory Services B.V.
  • Zoetis B.V.


  • ARCHE Consulting
  • Cargill R and D Centre Europe
  • Huvepharma
  • Inovet
  • Janssen Pharmaceutica NV
  • Medicem NV
  • VMD
  • Zoetis Belgium S.A.


  • Dynea AS
  • Nordly Holding AS
  • Pharmaq AS
  • Pharmaq AS, part of Zoetis
  • VESO
  • VESO Aqualab


  • Contura International A/S
  • Jacobsen Pharma & MedTech Advice A/S
  • Leo Animal Health As


  • Chanelle Pharmaceutical Manufacturing Ltd.
  • Cross Vetpharm Group Ltd
  • Hygeia
  • Hygeia Chemicals Limited


  • Bayer SpA
  • Ceva Salute Animale SPA
  • Fatro SpA
  • MSD Animal Health SRL


  • Novartis Animal Health Inc
  • Swiss Medic
  • Swissmedic


  • Orion Corporation
  • Orion Corporation Orion Pharma
  • Vetcare Oy


  • Gide Serviços - Investigação Quimica e Farmaceutica, S.A.
  • Hifarmax, Produtos e Serviços Veterinários, Lda.


  • Indukern SA
  • Novus Spain SA


  • Tiflovet Ltd


  • Billev farmacija vzhod d.o.o
  • Billev Pharma East


  • Vana GmbH


  • Novartis Animal Health Canada


  • Agencia Inhouse

Isle of Man

  • SEQ Limited


  • Nippon Zenyaku Kogyo Co., Ltd.


  • Food & Veterinary Service


  • Medicines and Medical Devices Agency of Serbia


  • FarmPharma


  • Merial

United States of America

  • Merial

Enrol or reserve

Run Veterinary Pharmaceutical Submissions in the EU Live online/Classroom for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • 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:

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

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749