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 the development
- Consider the implications of the ongoing review of the Veterinary Medicines Regulations
Ms Tamsin Dawson,
Veterinary product development consultancy group ,
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.
Ms Mel Munro,
Mel 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 Mel 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.
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)