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 development
- Consider the implications of the ongoing review of the Veterinary Medicines Regulations
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
A practical guide to the EU regulatory framework for veterinary vaccines
- Regulatory bodies
- Key legislation and guidance
- Update on the legislation review
Meeting the requirements of the marketing authorisation dossier - part 2: quality
- Legislation and guidance
- Layout and content of the Part 2 dossier
Meeting the requirements of the marketing authorisation dossier - part 3: safety
- Legislation and guidance
- Data requirements for the demonstration of safety
- Layout of the Part 3 dossier
Meeting the requirements of the marketing authorisation dossier - part 4: efficacy
- Legislation and guidance
- Data requirements for the demonstration of efficacy
- Layout of the Part 4 dossier
Day 2
Using the summary of product characteristics (SmPC) as a tool for development
Planning a vaccine development - introduction and workshop
Workshop - groups report back and Q&A
Preparing the dossier submission
- Marketing authorisation dossier - Part 1: Administrative documentation, DACS and benefit risk assessments and product information
- Tips on dossier writing and e-submissions
European licensing procedures and regulatory strategy
- Centralised procedure
- Decentralised procedure
- Mutual recognition procedure
- Regulatory strategy
Seeking regulatory advice and development of novel vaccines
- Meetings with regulators
- Scientific advice
- Innovation Task Force (ITF)
Procedures aimed at promoting innovation and vaccine availability
- Minor use/minor species (MUMS) classification
- Small/medium enterprise (SME) designation
- EMA network strategy 2020
Who Should Attend
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)
