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.
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.
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
Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
Programme - Day 1
A Practical Guide of EU Regulatory Framework for Veterinary Vaccines
- Regulatory bodies & key legislation and guidance
- Update on the legislation review
- Dossier – Part 2: Quality
- Dossier – Part 3: Safety
- 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
Ms Juliet Greenslade,
Juliet has over 16 years experience working in the Animal Health Industry. Her degrees are in Immunology and Medical Microbiology.
Juliet 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”, Juliet took responsibility for developing and registering new products, life-cycle maintenance of existing products and advising on regulatory strategy.
In Juliet’s 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.
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 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.
The Cavendish Hotel
81 Jermyn Street