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Management Forum

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.

8-9 July 2024
+ 11-12 November 2024 »
from £1099

Need help? Enrol or reserve

Format: Live online, Classroom
CPD: 12 hours for your records
Certificate of completion

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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:

This course forms part of our selection of Animal Health training courses, designed to keep you up to date with the latest regulations surrounding veterinary medicines, animal feeds, and industry best practices.

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)

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The A Practical Approach to Veterinary Vaccine Development and Registration in the EU course will cover:

Day 1
Day 2

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

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

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Mel Munro
knoell Animal Health

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.

More details

NEW higher discounts for multiple bookings - 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*

Please contact us for pricing if you are interested in booking 5 or more delegates

8-9 July 2024

Live online

08:30-15:30 UK (London) (UTC+01)
09:30-16:30 Paris (UTC+02)
03:30-10:30 New York (UTC-04)
Course code 13796

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 03 Jun

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

Online registration unavailable: this date is nearing full capacity; please contact us to register.

11-12 November 2024

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 14041
Optional £240/€312/$360 per night

GBP 1,299 1,499
EUR 1,869 2,149
USD 2,137 2,449

Until 07 Oct

2 days classroom-based training
Optional accommodation - 2 nights including breakfast, checking in the day before the course
Meet presenters and fellow attendees in person
Lunch and refreshments provided
Download documentation and certification of completion
Fair transfer and cancellation policy

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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.