This meeting 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.
This seminar has been designed to give practical advice and guidance on how to successfully develop a veterinary vaccine and achieve market approval in the EU. The programme will take a step-by-step approach to the process with a workshop to help delegates gain a better understanding of the requirements in practice. There will be ample time for discussion during the two days.
Benefits of attending:
This meeting runs back-to-back with Registration of Veterinary Vaccines in the USA and Canada on 2 May 2019 and there is a £200/€280 discount off when booked together with this programme.
To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail firstname.lastname@example.org
This seminar will be beneficial to all those working with veterinary vaccines from development to market approval and will provide a comprehensive insight into the requirements to achieve a successful application.
The programme will be of particular interest to:
A practical guide to the EU regulatory framework for veterinary vaccines
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 (SmPC) as a tool for development
Planning a vaccine development – introduction and workshop
Workshop – groups report back and Q&A
Seeking regulatory advice and development of novel vaccines
Procedures aimed at promoting innovation and vaccine availability
Preparing the dossier submission
European licensing procedures and regulatory strategy
We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.