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.
Sponsored by:
CPD Hours: 12
Course Content
- Day 1
- A practical guide to the EU regulatory framework for veterinary vaccines
- Procedures aimed at promoting veterinary vaccine availability
- Meeting the requirements of the marketing authorisation dossier - part 2: quality
- Meeting the requirements of the marketing authorisation dossier - part 3: safety
- Meeting the requirements of the marketing authorisation dossier - part 4: efficacy
- Using the summary of product characteristics (SPC) as a tool for development
- Planning a vaccine development (safety or efficacy) - introduction and workshop
- Workshop - groups report back and Q&A
- Development of novel vaccines - seeking regulatory advice
- Preparing & submitting the dossier
- European licensing procedures and regulatory strategy
Speakers
Mel Munro
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.
Michael Fontaine
Michael holds a PhD in molecular bacteriology, and has over 25 years of experience in the discovery and development of biological products for the animal health industry. His early experience was at the interface between academia and industry, within the applied environment of animal health research institutes in North America and the UK, where he led projects studying host-pathogen interactions to inform the discovery of new vaccines and diagnostics, on behalf of leading animal health companies.
Michael subsequently moved into animal health industry roles, and has held senior positions within Benchmark Animal Health and Virbac, with responsibility for directing the development of new biological products, with an emphasis on generating the Quality, Safety and Efficacy data necessary to support successful product registrations. He has worked with a range of different biological technology platforms and has used his collective knowledge and experience to provide support for a variety of biotechnology companies in his later role as an independent consultant, prior to joining the knoell team in early 2024.
