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

This meeting 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.

10-11 Mar 2020

GBP 1,399
EUR 1,959
USD 2,182

Book now

Course overview

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This seminar has been designed to give practical advice and guidance on how to successfully develop a veterinary vaccine and achieve market approval in the EU. The programme will take a step-by-step approach to the process with a workshop to help delegates gain a better understanding of the requirements in practice. There will be ample time for discussion during the two days.

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

Book both

This meeting runs back-to-back with Registration of Veterinary Vaccines in the USA and Canada on 12 March 2020 and there is a £200/€280 discount off when booked together with this programme.

To register on both events events click HERE

To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk

Who should attend

This seminar will be beneficial to all those working with veterinary vaccines from development to market approval and will provide a comprehensive insight into the requirements to achieve a successful application.

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

Programme - Day 1

A practical guide to the EU regulatory framework for veterinary vaccines

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

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

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

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

Q&A session

Programme - Day 2

Planning a vaccine development – introduction and workshop

Workshop – groups report back and Q&A

Seeking regulatory advice and development of novel vaccines

Procedures aimed at promoting innovation and vaccine availability

Preparing the dossier submission

European licensing procedures and regulatory strategy

Q&A session

Presenters

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.

Tamsin Dawson

Dr Tamsin Dawson has worked in the development and regulation of animal health products since 2005, having started her career in analytical method development. In her current role at the veterinary product development consultancy group, Triveritas, she supports clients on a range of veterinary vaccine, pharmaceutical, and feed additive product developments and registrations. This includes assessing the suitability of data for a European submission, as well as writing reports and dossiers for regulatory submissions, managing regulatory procedures, and responding to assessor’s questions on behalf of clients.

Book now

10-11 Mar 2020
10-11 Mar 2020 Rembrandt Hotel, London GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Abic Biological Laboratories Ltd.
  • Boehringer Ingelheim
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim VRC GmbH & Co KG
  • Ceva Phylaxia Ltd.
  • Cyton Biosciences Ltd
  • CZ Veterinaria SA
  • CZ Veterinaria, S.A.
  • Dyntec s.r.o.
  • Eco Animal Health Ltd
  • Fatro SpA
  • Genera
  • Laboratorios Ovejero SA
  • Lohmann Animal Health GmbH
  • Merial
  • MERIAL - Comptabilité Fournisseurs
  • National Drug Authority
  • Novartis, Centre de Recherche
  • Pharmaq AS
  • PHARMAQ Spain Aqua
  • Research and Markets
  • Salfarm Danmark A/S
  • Semigator GmbH
  • United Vaccines Inc
  • VESO
  • Vetia Animal Health S.A.
  • Virbac Laboratories
  • ViroVet BVBA
  • ViroVet NV
  • Zoetis

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.

Maria del Rocio Leon Kempis, Head of Bacteriology, BIVRC GmbH Co. & KG

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

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

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

Interesting and useful

Eleonora Bastino, Senior Associate Regulatory Affairs , Zoetis

The training was great, it fully met my expectations.

Louise Foster, Regulatory Manager, Semigator GmbH

Well presented in a cohesive structure - in the time. Content was adequately addresses and explained

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

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

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

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

The course was excellent insofar 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

I am satisfied!

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

Very good and interesting

Amandine Bibard, , Merial Business

Excellent

Marie Lovoll, Research Director, VESO

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

Charlène Ferrand, Global Regulatory Affairs Manager, Merial Business

Very good opportunity

Luciano Gobbi, Associate Director Regulatory Affairs, MSD Animal Health SRL