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.
2 May 2019
Understand the licensing of veterinary vaccines by USDA and CFIA
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 seminar will explain the licensing process for vaccines with USDA and CFIA, and will provide comprehensive insight into the requirements to achieve a successful application.
This meeting runs back-to-back with A Practical Approach to Veterinary Vaccine Development and Registration in the EU on 30 April – 1 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 who require an understanding of the licensing process in the USA and Canada.
Regulatory framework for veterinary vaccines in Canada and USA
Requirements for a U.S. veterinary biologics product license
Transferability of EU dossiers for USDA submission
Workshop: Challenges of designing a study to meet both EU and USDA requirements
Permits, Establishment License and Inspections
Q&A and close of forum
Donna Mattson has worked in vaccine development and registration in the North American market since 1995. Initially hired as 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 Global Director, 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.