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Management Forum

A Practical Approach to Veterinary Vaccine Development and Registration in the EU (European Union) Training Course

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.

★★★★★ "My intent was to get an overall picture of the lay out of a vaccine registration dossier, content an... more"

15-16 Sep 2022

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  • Format: Classroom
  • 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

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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 for over 20 years. She provides regulatory advice on all areas of biologicals product development taking client projects from proof of concept through to Marketing Authorisation (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 and preparing regulatory documentation. Over her career she has been involved in numerous biologicals projects ranging from more ‘conventional’ vaccines to novel biologicals such as products of rDNA technology, GMO’s, monoclonal antibodies, DNA vaccines and gene therapy.


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Tamsin Dawson

Dr Tamsin Dawson has worked in animal health product development and registration since 2005 and started her career in industry in an analytical method development & validation role. In her current position as project manager at knoell, Tamsin support clients on a range of veterinary vaccine/biologicals and feed additive product developments and registrations. This includes assessing data suitability for European applications (quality, safety & efficacy) and providing strategic regulatory advice and practical regulatory support such as dossier writing and managing regulatory procedures. Tamsin also advises on appropriate study designs and statistical considerations for the conduct of target animal studies.



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

15-16 Sep 2022

Classroom
Rembrandt Hotel
London

09:15-17:00 UK (London)
Course code 11840

  • GBP 1,199 1,399
  • EUR 1,679 1,959
  • USD 1,870 2,182

Until 11 Aug

  • 2 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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* 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 A Practical Approach to Veterinary Vaccine Development and Registration in the EU training course


My intent was to get an overall picture of the lay out of a vaccine registration dossier, content and submission timelines. Thanks to the extensive course, I got a full and complete tool box.

Mar 17 2022

Frédérique Cernicchiaro
Specialiste Pharmacovigilance Globale, Boehringer Ingelheim

Mar 17 2022

My intent was to get an overall picture of the lay out of a vaccine registration dossier, content and submission timelines. Thanks to the extensive course, I got a full and complete tool box... the webinar has been very enjoyable, informative. Congratulations to both speakers because It is not an easy exercise when addressing attendants through screens.

Frédérique Cernicchiaro
Specialiste Pharmacovigilance Globale, Boehringer Ingelheim

Mar 17 2022

I think it was especially helpful for the slightly advanced in these areas.

Ladislav Pazout
Production director, DYNTEC, spol. s r. o.

Mar 10 2020

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

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

United Kingdom

  • 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

Czech Republic

  • Dyntec s.r.o.
  • DYNTEC, spol. s r. o.

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

Finland

  • Vetcare Oy

Israel

  • Phibro Animal Health

Netherlands

  • Zoetis BV

Switzerland

  • Novartis, Centre de Recherche

Uganda

  • National Drug Authority

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Run A Practical Approach to Veterinary Vaccine Development and Registration in the EU Classroom for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • 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