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.
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 since 2002. She provides regulatory advice on all areas of VMP development taking ideas for veterinary medicines from proof of concept right through to Marketing Authorisations (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, preparing reports, documents and dossiers to support MA submissions as well as managing regulatory procedures and assisting clients with regulatory referrals. Over her career she has been involved in various biologicals development projects ranging from more ‘conventional’ vaccines to novel biologicals containing products of rDNA technology and GMO’s.
Tamsin Dawson (More...)
Dr Tamsin Dawson has worked in animal health product development and registration since 2005, having started her career in industry in an analytical method development & validation role. Her current project manager position at the consultancy group, knoell Animal Health Ltd., sees her support clients on a range of veterinary vaccine/biological, and feed additive product developments and registrations. This includes assessing the suitability of data for a European application & providing strategic regulatory advice on pathways to market and data generation for all areas (quality, safety & efficacy). She also writes dossiers for regulatory submissions, manages regulatory procedures on behalf of clients, including responding to assessor questions, and assists with marketing authorisation (MA) maintenance procedures.
Book now
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17-18 Mar 2022 Live webinar |
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17-18 Mar 2022 Live webinar |
GBP 1,199 999 EUR 1,719 1,439 USD 1,942 1,630 Until 10 Feb 22* |
Enrol now
to attend Live webinar |
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6-7 Sep 2022 Live webinar |
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6-7 Sep 2022 Live webinar |
GBP 1,199 999 EUR 1,719 1,439 USD 1,942 1,630 Until 2 Aug 22* |
Enrol now
to attend Live webinar |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code