This course will cover some of the most complex yet fundamental aspects of veterinary vaccines licensing by USDA and CFIA including the phased submission process as well as the format and content specifications for the required dossier components.
Veterinary biological products, including vaccines, are regulated independently of veterinary pharmaceuticals and topical insecticides/pesticides in Canada and the USA. Three different acts, with associated regulations and guidance, govern the three different product categories, with the result that regulation is quite dissimilar. The requirements for licensing of vaccines with USDA and CFIA are also significantly different from those for licensing of vaccines in the individual EU member states, or centrally in the EU.
This intensive one-day course will explain the licensing process for vaccines with USDA and CFIA, and will provide comprehensive insight into the requirements to achieve a successful application.
The programme will address the transferability of EU dossiers for USDA submission, which will be beneficial in planning your regulatory strategy.
Benefits of attending:
This meeting runs back-to-back with A Practical Approach to Veterinary Vaccine Development and Registration in the EU on 10-11 March 2020 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 programme will be key to all those working with veterinary vaccines who require an understanding of the licensing process in the USA and Canada, including:
Regulatory framework for veterinary vaccines in Canada and USA
Requirements for a US Veterinary Biologics Product License
Transferability of EU dossiers for USDA submission
Recent changes to the regulations and guidance
Permits, establishment licence and inspections
- Facility documentation, blueprints, plot plans, legends and addenda, personnel qualifications and experience
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.