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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.

17-18 Mar 2022

& 6-7 Sep 2022

Book now

Details

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)

Programme

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

Presenters

Mel Munro (More...)

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.

Tamsin Dawson (More...)

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.

Book now

Book now

17-18 Mar 2022
Live webinar
17-18 Mar 2022
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 10 Feb 22*
Enrol now
to attend
Live webinar
6-7 Sep 2022
Live webinar
6-7 Sep 2022
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 2 Aug 22*
Enrol now
to attend
Live webinar

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 12 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

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Previous customers include...

  • Abic Biological Laboratories Ltd.
  • Animal and Plant Health Agency (APHA)
  • Aratana Therapeutics NV
  • Benchmark Animal Health Ltd
  • BIVRC GmbH & Co KG
  • Boehringer Ingelheim
  • BOEHRINGER INGELHEIM - ANIMAL HEALTH FRANCE
  • Boehringer Ingelheim Veterinary Research Center GmbH &Co. KG
  • Boehringer Ingelheim Vetmedica GmbH
  • Boehringer Ingelheim Vetmedica Inc
  • Boehringer Ingelheim VRC GmbH & Co KG
  • Ceva Phylaxia Ltd.
  • CZ Veterinaria, S.A.
  • Dyntec s.r.o.
  • Fatro SpA
  • Hertape SA
  • Lohmann Animal Health GmbH
  • MERIAL - Comptabilité Fournisseurs
  • MSD Animal Health SRL
  • Novartis, Centre de Recherche
  • Pharmaq AS, part of Zoetis
  • PHARMAQ Spain Aqua
  • Research and Markets
  • Salfarm Danmark A/S
  • Semigator GmbH
  • Triveritas
  • Vetcare Oy
  • Vetia Animal Health S.A.
  • ViroVet BVBA
  • ViroVet NV

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, Mar 20

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 18

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

Begoña Garcia Monelos, Regulatory Affairs Technician, CZ Veterinaria, S.A., Oct 18

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, Oct 18

Interesting and useful.

Eleonora Bastino, Senior Associate Regulatory Affairs , Zoetis, Apr 18

The training was great, it fully met my expectations.

Louise Foster, Regulatory Manager, Semigator GmbH, Apr 18

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, Oct 17

I am satisfied!

Ágnes Bárdi, Registration Expert, Ceva - Phylaxia Veterinary Biologicals co. Ltd., Apr 17

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 17

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, Apr 17

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

Anna-Paola Colombo, Methods Process Improvement Specialist, Merial SAS, Apr 17

Excellent.

Marie Lovoll, Research Director, VESO, Oct 16

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

Charlène Ferrand, Global Regulatory Affairs Manager, Merial Business, Oct 16

Very good and interesting.

Amandine Bibard, Merial Business, Oct 16