Presented by
Management Forum

A Practical Approach to Veterinary Vaccine Development and Registration in the EU

This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.

17-18 Mar 2022 + 1 more date

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

Course overview

Demand for biologics in veterinary medicine is increasing. However, developing vaccines and successfully obtaining market authorisation brings its own complex and challenging issues.

This course has been designed to give practical advice and guidance on how to successfully develop a veterinary vaccine and achieve market approval in the EU, ensuring that participants gain a comprehensive insight into the necessary requirements.

The programme will take a step-by-step approach to the process and will include a workshop to help delegates gain a better understanding of the requirements in practice. There will be ample time for discussion throughout the two days with our expert faculty and fellow professionals.

Benefits of attending:

  • Recognise the key legislation and guidance and how to use this to plan an effective veterinary vaccine development
  • Understand what data you need to generate for your application and how to present this in your dossier
  • Gain an insight into the different routes to market and how to submit your dossier for market approval
  • Learn how and when to seek regulatory advice during development
  • Consider the implications of the ongoing review of the Veterinary Medicines Regulations

Sponsored by:




Who should attend?

This event will be beneficial to all those working with veterinary vaccines from development to market approval.

The programme will be of particular interest to:

  • New entrants to registration departments
  • Veterinary medicinal product manufacturers
  • Registration managers
  • Research and development departments
  • Academics with an interest in commercialising opportunities
  • Personnel from micro/small and medium-sized enterprises (SMEs)

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The A Practical Approach to Veterinary Vaccine Development and Registration in the EU course will cover:

A practical guide to the EU regulatory framework for veterinary vaccines

  • Regulatory bodies
  • Key legislation and guidance
  • Update on the legislation review

Meeting the requirements of the marketing authorisation dossier – Part 2: Quality

  • Legislation and guidance
  • Layout and content of the Part 2 dossier

Meeting the requirements of the marketing authorisation dossier – Part 3: Safety

  • Legislation and guidance
  • Data requirements for the demonstration of safety
  • Layout of the Part 3 dossier

Meeting the requirements of the marketing authorisation dossier – Part 4: Efficacy

  • Legislation and guidance
  • Data requirements for the demonstration of efficacy
  • Layout of the Part 4 dossier

Using the summary of product characteristics (SmPC) as a tool for development

Preparing the dossier submission

  • Marketing authorisation dossier – Part 1: Administrative documentation, DACS and benefit risk assessments and product information
  • Tips on dossier writing and e-submissions

European licensing procedures and regulatory strategy

  • Centralised procedure
  • Decentralised procedure
  • Mutual recognition procedure
  • Regulatory strategy

VMP Regulation, Review and Changes

Procedures aimed at promoting innovation and vaccine availability

  • Minor use/minor species (MUMS) classification
  • Small/medium enterprise (SME) designation
  • EMA network strategy 2020

Seeking regulatory advice and development of novel vaccines

  • Meetings with regulators
  • Scientific advice
  • Innovation Task Force (ITF)

Planning a vaccine development – introduction and workshop

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Mel Munro

Dr Mel Munro has worked as a consultant in veterinary medicinal product development and registration since 2002. She provides regulatory advice on all areas of VMP development taking ideas for veterinary medicines from proof of concept right through to Marketing Authorisations (MA). On a day-to-day basis, she advises on regulatory strategy, performs technical due diligence and gap analyses and prepares strategic development plans and expert reports. She is also experienced in negotiation with the regulators, preparing reports, documents and dossiers to support MA submissions as well as managing regulatory procedures and assisting clients with regulatory referrals. Over her career she has been involved in various biologicals development projects ranging from more ‘conventional’ vaccines to novel biologicals containing products of rDNA technology and GMO’s.

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Tamsin Dawson

Dr Tamsin Dawson has worked in animal health product development and registration since 2005, having started her career in industry in an analytical method development & validation role. Her current project manager position at the consultancy group, knoell Animal Health Ltd., sees her support clients on a range of veterinary vaccine/biological, and feed additive product developments and registrations. This includes assessing the suitability of data for a European application & providing strategic regulatory advice on pathways to market and data generation for all areas (quality, safety & efficacy). She also writes dossiers for regulatory submissions, manages regulatory procedures on behalf of clients, including responding to assessor questions, and assists with marketing authorisation (MA) maintenance procedures.

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Book A Practical Approach to Veterinary Vaccine Development and Registration in the EU Live online training

17-18 Mar 2022

Live online

09:15-17:00 UK (London) (UTC+00)
10:15-18:00 Paris (UTC+01)
05:15-13:00 New York (UTC-04)
Course code 11567

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

Until 10 Feb

In your basket 

6-7 Sep 2022

Live online

09:15-17:00 UK (London) (UTC+01)
10:15-18:00 Paris (UTC+02)
04:15-12:00 New York (UTC-04)
Course code 11840

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

Until 02 Aug

In your basket 

Reviews of IPI's A Practical Approach to Veterinary Vaccine Development and Registration in the EU training course


The practical session was very useful, with suitable supporting material for reference, and feedback on interpretation of the monographs

Mar 10 2020

Jonathan Welch
Development Manager (Vaccines), Benchmark Animal Health Ltd

Oct 16 2018

The course was really good, a lot of info packed into two days, but straight forward and logical. The course gave a good overview without going too much into specific details. The workshop was great and really helped a lot for understanding requirements better.

Sebastian Bubendorfer
Scientist, Boehringer Ingelheim Veterinary Research Center GmbH & Co. KG

Oct 16 2018

As you can imagine, the seminar content can be a bit arid for a scientist who is always dealing with lab experiments. Well, I was very surprised by how much the presenters had to share from their vast experience and made sure the course was not only presenting information. They were very dynamic, understood where the questions were coming from and always made sure we got our doubts clarified.

Rocío Leon-Kempis
Head of Bacteriology, Boehringer Ingelheim Veterinary Research Center GmbH & Co. KG

Apr 17 2018

The training was great, it fully met my expectations.

Louise Foster
Regulatory Manager, Semigator GmbH

Apr 17 2018

Interesting and useful.

Eleonora Bastino
Senior Associate Regulatory Affairs , Zoetis

Oct 16 2018

Good approach to obtain an overview about regulatory affairs. Clear presentations.

Begoña Garcia Monelos
Regulatory Affairs Technician, CZ Veterinaria, S.A.

Oct 18 2017

The speakers were very knowledgeable and provided pertinent suggestions and the course was well presented with a cohesive structure. Content was adequately addressed and explained.

Beverley Taylor
Senior Manager, Regulatory Affairs, Eco Animal Health Ltd

Apr 26 2017

Interesting training, useful for people not only from RA. Documentation complete and helpful.

Anna-Paola Colombo
Methods Process Improvement Specialist, Merial SAS

Apr 26 2017

The course was excellent in so far as it was tailored to individual needs and requirements. The materials provided are invaluable; they will help me with future projects. Overall a thoroughly enjoyable and useful training course.

Callum Scott
Vaccine Development Manager, Benchmark Animal Health Ltd

Apr 26 2017

I am satisfied!

Ágnes Bárdi
Registration Expert, Ceva - Phylaxia Veterinary Biologicals co. Ltd.

Apr 26 2017

Great course. Would recommend. I appreciate that it is narrowed down to veterinary vaccine development in the EU. Most other courses I have come across covers many RA topics at once but this was more targeted. Even so, there was plenty of material to go through and we could get a bit more in depth.

Matias Nilsson
Regulatory Affairs Specialist & QPPV, Salfarm Danmark A/S

Oct 19 2016

Very good and interesting.

Amandine Bibard
Merial Business

Oct 19 2016

Excellent.

Marie Lovoll
Research Director, VESO

Oct 19 2016

Very interesting presentations and workshop to have a global overview of EU requirements and procedures .

Charlène Ferrand
Global Regulatory Affairs Manager, Merial Business

Oct 19 2016

Very good opportunity.

Luciano Gobbi
Associate Director Regulatory Affairs, MSD Animal Health SRL

Germany

  • Bayer Animal Health GmbH
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Veterinary Research Center GmbH & Co. KG
  • Boehringer Ingelheim Veterinary Research Center GmbH &Co. KG
  • Boehringer Ingelheim Vetmedica GmbH
  • Boehringer Ingelheim VRC GmbH & Co KG
  • Lohmann Animal Health
  • Lohmann Animal Health GmbH
  • Semigator GmbH

France

  • Boehringer Ingelheim
  • BOEHRINGER INGELHEIM ANIMAL HEALTH FRANCE
  • CEVA Sante Animale
  • Merial
  • Merial Business
  • Merial SAS
  • Virbac Laboratories

Spain

  • CZ Veterinaria SA
  • CZ Veterinaria, S.A.
  • CZVeterinaria
  • Laboratorios Ovejero SA
  • PHARMAQ Spain Aqua
  • Vetia Animal Health S.A.

Belgium

  • Aratana Therapeutics NV
  • Elanco Animal Health
  • ViroVet BVBA
  • ViroVet NV
  • Zoetis

UK

  • Animal and Plant Health Agency (APHA)
  • Benchmark Animal Health
  • Benchmark Animal Health Ltd
  • Eco Animal Health Ltd

Norway

  • Pharmaq AS
  • Pharmaq AS, part of Zoetis
  • VESO

United States of America

  • Boehringer Ingelheim Animal Health
  • Boehringer Ingelheim Vetmedica Inc
  • United Vaccines Inc

Denmark

  • DTU, National Veterinary Institute
  • Salfarm Danmark A/S

Hungary

  • Ceva - Phylaxia Veterinary Biologicals co. Ltd.
  • Ceva Phylaxia Ltd.

Italy

  • Fatro SpA
  • MSD Animal Health SRL

Austria

  • Boehringer Ingelheim

Brazil

  • Hertape SA

Canada

  • Triveritas

Croatia

  • Genera

Czech Republic

  • Dyntec s.r.o.

Finland

  • Vetcare Oy

Israel

  • Abic Biological Laboratories Ltd.

Netherlands

  • Zoetis BV

Switzerland

  • Novartis, Centre de Recherche

Uganda

  • National Drug Authority

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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