A Practical Approach to Veterinary Vaccine Development and Registration in the EU (European Union) Training Course
This event 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.
15-16 Sep 2022
Details
Course overview
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
Sponsored by:
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)
Programme
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
Using the summary of product characteristics (SmPC) as a tool for development
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
VMP Regulation, Review and Changes
Procedures aimed at promoting innovation and vaccine availability
- Minor use/minor species (MUMS) classification
- Small/medium enterprise (SME) designation
- EMA network strategy 2020
Seeking regulatory advice and development of novel vaccines
- Meetings with regulators
- Scientific advice
- Innovation Task Force (ITF)
Planning a vaccine development – introduction and workshop
Presenters
Mel Munro (More...)
Dr Mel Munro has worked as a consultant in veterinary medicinal product development and registration for over 20 years. She provides regulatory advice on all areas of biologicals product development taking client projects from proof of concept through to Marketing Authorisation (MA). On a day-to-day basis, she advises on regulatory strategy, performs technical due diligence and gap analyses and prepares strategic development plans and expert reports. She is also experienced in negotiation with the regulators and preparing regulatory documentation. Over her career she has been involved in numerous biologicals projects ranging from more ‘conventional’ vaccines to novel biologicals such as products of rDNA technology, GMO’s, monoclonal antibodies, DNA vaccines and gene therapy.
Tamsin Dawson (More...)
Dr Tamsin Dawson has worked in animal health product development and registration since 2005 and started her career in industry in an analytical method development & validation role. In her current position as project manager at knoell, Tamsin support clients on a range of veterinary vaccine/biologicals and feed additive product developments and registrations. This includes assessing data suitability for European applications (quality, safety & efficacy) and providing strategic regulatory advice and practical regulatory support such as dossier writing and managing regulatory procedures. Tamsin also advises on appropriate study designs and statistical considerations for the conduct of target animal studies.
Book now
Book now
NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
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15-16 Sep 2022 Face-to-face, Rembrandt Hotel London 09:15-17:00 UK (London) |
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15-16 Sep 2022 Face-to-face Rembrandt Hotel London 09:15-17:00 UK (London) |
GBP 1,399 1,199 EUR 1,959 1,679 USD 2,182 1,870 Until 11 Aug* |
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to attend Face-to-face Rembrandt Hotel London |
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* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.