Presented by
Management Forum

Veterinary Pharmaceutical Submissions in the EU

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

6-7 Dec 2021 + 2 more dates

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  • Format: Live online
  • CPD: 12 hours for your records
  • Certificate of completion

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; detailed and critical summaries; 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 the detailed and critical summaries on safety
  • Consider the pre-clinical and clinical requirements
  • Take away regulatory strategies and procedures
  • Acquire the skills to write the regulatory submission

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.

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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

Workshop session

Planning a dossier to contain:

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

Part IIIA: Consumer and environmental safety data requirements

  • The toxicological package
  • Maximum residue limits dossier: safety file
  • Part IIIA of the marketing authorisation application

User safety risk assessment

  • Reviewing toxicology studies
  • Setting the scenario
  • Risk assessment and management

Pharmacokinetics and bioequivalence

Environmental risk assessment

  • Phase I and II assessments

Part IIIB: Residues

  • Metabolism and residue studies
  • Maximum residue limits dossier: residues file
  • Withdrawal period
  • Part IIIB of the marketing authorisation application

Detailed and critical summaries on safety and residues

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

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Julian Braidwood

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. Julian 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 co-founded Triveritas in 2,000 which grew rapidly internationally and became part of knoell in 2021. knoell is one of the leading service providers for worldwide registration and regulatory compliance in crop protection, crop nutrition, chemicals, cosmetics, animal health products, and medical devices. The knoell Group employs almost 600 people worldwide in more than 14 countries.

knoell is the only knowledge-based animal health consultancy and clinical studies specialist with its own technical staff based on three continents: North America, Europe, and Asia. The animal health team offers a full portfolio of services, including start-to-finish product development and ad hoc services – in all domesticated species for pharmaceuticals and biologicals, feed additives, novel, generic and borderline products.

More details

Book Veterinary Pharmaceutical Submissions in the EU Live online training

6-7 Dec 2021

Live online

09:00-16:30 UK (London) (UTC+00)
10:00-17:30 Paris (UTC+01)
04:00-11:30 New York (UTC-05)
Course code 11146

  • GBP 999 1,199
  • EUR 1,439 1,719
  • USD 1,630 1,942

Until 01 Nov

In your basket 

9-10 Jun 2022

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 11591

  • GBP 999 1,199
  • EUR 1,439 1,719
  • USD 1,630 1,942

Until 05 May

In your basket 

13-14 Dec 2022

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 11788

  • GBP 999 1,199
  • EUR 1,439 1,719
  • USD 1,630 1,942

Until 08 Nov

In your basket 

Reviews of IPI's Veterinary Pharmaceutical Submissions in the EU training course


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

Mar 3 2021

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
QPPV, ZOOPAN S.A.

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

UK

  • Animalcare Ltd
  • Benchmark Animal Health
  • Benchmark Vaccines Ltd
  • British American Tobacco (Investments) Limited
  • Cyton Biosciences Ltd
  • Cyton Biosciences Ltd.
  • Danisco (UK) Limited
  • 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.
  • MASTERFOODS
  • NOAH ltd
  • Norbrook Laboratories Ltd
  • Novartis Animal Health UK Ltd
  • Pfizer Limited
  • PROBIOTICS INT LTD
  • Veterinary Medicines Directorate
  • VETOQUINOL UK LTD
  • Vita (Europe) Ltd
  • Zoetis

Netherlands

  • 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.
  • ORFFA INTERNATIONAL HOLDING BV
  • Zoetis B.V.

France

  • Boehringer Ingelheim
  • CEVA SANTE ANIMAL
  • CEVA Sante Animale
  • Galderma R&D
  • Merial Business
  • Merial SAS
  • Sogeval Laboratories
  • Vetoquinol SA
  • Virbac Corporation

Germany

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

Belgium

  • ARCHE Consulting
  • Huvepharma
  • Inovet
  • Janssen Pharmaceutica NV
  • Medicem NV
  • VMD
  • Zoetis Belgium S.A.

Norway

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

Italy

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

Switzerland

  • DR. E. GRAEUB AG
  • Novartis Animal Health Inc
  • Swiss Medic
  • Swissmedic

Denmark

  • DANISH INST FOOD AND VET RESEARCH
  • Jacobsen Pharma & MedTech Advice A/S
  • Leo Animal Health As

Finland

  • Orion Corporation Orion Pharma
  • Vetcare Oy

Hungary

  • SELBRUHA Kft.
  • Tiflovet Ltd

Ireland

  • Chanelle Pharmaceutical Manufacturing Ltd.
  • Cross Vetpharm Group Ltd

Portugal

  • Hifarmax, Produtos e Serviços Veterinários, Lda.
  • ZOOPAN S.A.

Spain

  • Indukern SA
  • KUBUS SA

Austria

  • Vana GmbH

Canada

  • Novartis Animal Health Canada

Isle of Man

  • SEQ Limited

Japan

  • Nippon Zenyaku Kogyo Co., Ltd.

Latvia

  • Food & Veterinary Service

Serbia

  • Medicines and Medical Devices Agency of Serbia

Slovenia

  • Billev Pharma East

Turkey

  • Merial

United States of America

  • Merial

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Multiple colleagues?
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