This In-house course provides an insight into the licensing of veterinary vaccines by USDA and CFIA, the phased submission process for vaccine licensing, and both 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 3 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 In-house programme will explain the licensing process for vaccines with USDA and CFIA, and will provide comprehensive insight into the requirements to achieve a successful application.
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Workshop: Study Design to Meet Both EU and USDA Requirements
Specified Format Documentation for USDA
Donna Mattson has been working in vaccine development and registration in the North American market since 1995. Initially in the capacity of a Quality Control technician with Biostar in Saskatoon, Canada, she took on the role of regulatory liaison with CFIA and since then has accumulated 20 years experience in regulatory affairs for veterinary vaccines in Canada and the USA.
She spent 5 years with Novartis Animal Vaccines, including one year in the UK office, followed by 9 years with Bioniche Animal Health in Canada where she was a Global Director of Regulatory Affairs, Veterinary Biologics. In 2014 she joined Triveritas in the UK office, gaining familiarity with the EU requirements for immunological products, including insight into the challenges of adapting EU dossiers to meet the requirements of USDA and CFIA. Having spent one year in the UK office she has now returned to Ontario Canada where she continues to work for Triveritas, assisting clients in vaccine licensing in Canada and the USA.
A unique aspect of North American vaccine registration is the requirement for an Establishment license. A product license is not issued in isolation, but must be issued concurrently with an Establishment license. The requirements of this license are specific to USDA and CFIA and are not similar to the requirements for any other type of product (drug, pesticide) within North America, nor are they similar to the EU requirements. In addition to vaccine development and registration experience, she has valuable experience in facility licensing with USDA and CFIA.