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.

16-17 Oct 2018

& 30 Apr-1 May 2019

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

Book now

Course Overview

Sponsored by

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 participants through a step-by-step approach to the process. The workshop will assist delegates to gain a better understanding of the requirements in practice. There will be ample time for discussion during the two days.

Book both

This meeting runs back-to-back with Registration of Veterinary Vaccines in the USA and Canada on 20 October 2017 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

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 (MA)
  • Learn how and when to seek regulatory advice during development
  • Consider the implications of the ongoing review of the Veterinary Medicines Regulation

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 to the requirements to achieve a successful application.
Personnel in the following areas will find this course useful:

  • New entrants to Registration Departments
  • Veterinary Medicinal Product Manufacturers
  • Registration Managers
  • Personnel within Research and Development Departments
  • Academics with an interest in commercialising opportunities
  • Personnel from Micro/Small Enterprises.

Programme - Day 1

A Practical Guide of EU Regulatory Framework for Veterinary Vaccines

  • Regulatory bodies & key legislation and guidance
  • Update on the legislation review

Marketing Authorisation

  • Dossier – Part 2: Quality

Marketing Authorisation

  • Dossier – Part 3: Safety

Marketing Authorisation

  • Dossier – Part 4: Efficacy

Using SPCs as a Tool for Development

Programme - Day 2

Planning a Vaccine Development – Workshop

Workshop – Groups Report Back and Q&A

Seeking Regulatory Advice During Planning and Development of Novel Vaccines

  • Scientific Advice, Innovation Task Force (ITF)

Procedures Aimed at Promoting Innovation

*Minor use / Minor species (MUMS) classification, Small/medium enterprise (SME) designation

Preparing the Dossier Submission

  • Marketing Authorisation Dossier – Part 1: Administrative documentation, DACS and Benefit Risk Assessments, Product Information and Labelling
  • Tips on e-Submissions

European Licensing Procedures and Regulatory Strategy

Presenters

Juliet Greenslade

Juliet Greenslade has over 19 years experience working in the Animal Health Industry. Her degrees are in Immunology and Medical Microbiology. She started her career as a Medical Microbiologist in a large teaching hospital (5 years) before moving into the Animal Health arena. Initially she worked as a Scientist and GLP study Director in Biologicals R&D at Intervet. After some 6.5 years doing this she moved into Regulatory Affairs, first with Schering-Plough as a Senior Regulatory Manager and then with Pfizer (now Zoetis) as an Associate Director before joining Triveritas in 2010. During her time working in “big pharma”, she took responsibility for developing and registering new products, life-cycle maintenance of existing products and advising on regulatory strategy. In her current role as Project Manager, Biologicals Regulatory Affairs, at Triveritas, she assists clients (large and small) in a variety of areas, from advising on regulatory strategy and product development, through to preparing Expert Reports, writing Dossiers and running regulatory procedures on behalf of clients.

Mel Munro

Mel Munro has worked in regulatory affairs in the Animal Health Industry since 2002. She has been involved in all aspects of veterinary vaccine development and spends most of her time assisting clients with Start-to-Finish projects, taking ideas for veterinary medicines from proof of concept right through to Marketing Authorisations (MA). On a daily basis she is responsible for preparing reports, documents and Dossiers for MA submissions, and for running National, Decentralised and Centralised Procedures. She also provides gap analysis of existing products and strategic advice on new product developments. Over her career she has been involved in various vaccine development projects ranging from inactivated and live viral and bacterial vaccines, to novel vaccines that include products of rDNA technology and GMO’s.

Book now

16-17 Oct 2018
16-17 Oct 2018 Cavendish Hotel, London GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
Enrol now
30 Apr-1 May 2019
30 Apr-1 May 2019 Cavendish 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.
  • Aratana Therapeutics NV
  • Benchmark Animal Health Ltd
  • BIVRC GmbH Co. & KG
  • Boehringer Ingelheim
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Veterinary Research Center GmbH & Co. KG
  • Boehringer Ingelheim Vetmedica Inc
  • Boehringer Ingelheim VRC GmbH & Co KG
  • Ceva - Phylaxia Veterinary Biologicals co. Ltd.
  • Ceva Phylaxia Ltd.
  • Cyton Biosciences Ltd
  • CZ Veterinaria SA
  • Eco Animal Health Ltd
  • Elanco Animal Health
  • Fatro SpA
  • Hertape SA
  • Laboratorios Ovejero SA
  • Lohmann Animal Health
  • Lohmann Animal Health GmbH
  • National Drug Authority
  • Pharmaq AS
  • Research and Markets
  • Salfarm Danmark A/S
  • Semigator GmbH
  • United Vaccines Inc
  • VESO
  • Vetcare Oy
  • ViroVet BVBA
  • Zoetis

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

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.

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

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

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

Very good and interesting

Amandine Bibard, , Merial Business

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

Excellent

Marie Lovoll, Research Director, VESO