A Practical Approach to Veterinary Vaccine Development and Registration in the EU (European Union) Training Course (Mar 10th - Mar 11th, 2026) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "A Practical Approach to Veterinary Vaccine Development and Registration in the EU (European Union) Training Course (Mar 10th - Mar 11th, 2026)" training has been added to ResearchAndMarkets.com's offering.

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

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)

Certifications:

• CPD: 12 hours for your records
• Certificate of completion

Key Topics Covered:

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

Speakers:

Mel Munro
Management Forum

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.

For more information about this training visit https://www.researchandmarkets.com/r/y6vavs

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