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.
13-14 September 2023
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 course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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:
Nick Wills is a regulatory affairs advisor with over 10 years of experience in Veterinary Biologics development in a regulatory and quality assurance capacity. In his current position as an Advisor for Veterinary Product Development at knoell Animal Health, Nick assists clients with a wide range of regulatory projects including licensing of new products, preparation of regulatory documents and inspection readiness. Nick’s prior experiences within a CRO/CMO, as well as within large veterinary biologics company allow him to bring USDA regulated expertise, ranging from licensing new products and preparing facilities for inspections to solving regulatory issues for existing products. Nick also has significant experience with labeling and registration of US products in foreign countries. Nick particularly enjoys the complicated problem solving and scientific elements of regulatory affairs work.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
13-14 September 2023
13:00-17:00 UK (London) (UTC+01)
14:00-18:00 Paris (UTC+02)
08:00-12:00 New York (UTC-04)
Course code 12728
Until 09 Aug
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for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: