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

This In-house course 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.

In-house Training and Consultancy Services

This In-house 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. 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.

Your next step is to call us now on +44 (0)20 7749 4730 or email us at info@management.forum.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample programme - Day one

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

Sample programme - Day two

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

Recommended trainers

Juliet Greenslade

Juliet Greenslade has over 16 years experience working in the Animal Health Industry and holds degrees in Immunology and Medical Microbiology. Having started out as a Medical Microbiologist in a large teaching hospital she moved into the Animal Health arena. Juliet had been working as a Scientist and GLP study Director in Biologicals R&D at Intervet for over 6 years when she developed a keen interest in Regulatory Affairs. That led her to join Schering-Plough where she took a position of a Senior Regulatory Manager and then Pfizer (now Zoetis) as an Associate Director. Juliet’s vast experience in “big pharma” includes developing and registering new products, life-cycle maintenance of existing products and advising on regulatory strategy. In her current role as a Project Manager of Biologicals Regulatory Affairs at Triveritas she assists clients 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 been working 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.