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.
14-15 Sep 2022
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 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 (More...)
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 booking multiple places - bring your colleagues to make your training budget go further:
14-15 Sep 2022 Live webinar 13:00-17:00 UK (London) |
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14-15 Sep 2022 Live webinar 13:00-17:00 UK (London) |
GBP 599 499 EUR 859 719 USD 970 814 Until 10 Aug* |
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* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.