Registration of Veterinary Vaccines in the USA and Canada

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

GBP 699
EUR 979
USD 1,090

Book now

Course Overview

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.

Sponsored by

Book both

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 register on both events events click HERE

To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk

Who should attend

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.

Programme

Regulatory framework for veterinary vaccines in Canada and USA

  • Biologics regulatory agencies and Acts
    • CFIA and USDA, Health of Animals Act, Virus-Serum-Toxin Act
  • Regulations
    • Code of Federal Regulations, Title 9 (9 CFR)
  • Guidance
    • Veterinary services memoranda, public notices, risk analyses and SIFs, SAMs, policy manuals, submission compliance book, electronic submissions

Requirements for a U.S. veterinary biologics product license

  • Categories of licenses issued by USDA CVB
  • Phased submission process
    • review/approval of documentation by CVB prior to advancement to next phase
    • CVB confirmatory testing and approval of master seeds, pre-licensing serials
  • Regulatory fee structure

Transferability of EU dossiers for USDA submission

  • Compare challenge and field study requirements
  • USDA dossier for EMA submission

Workshop: Challenges of designing a study to meet both EU and USDA requirements

Permits, Establishment License and Inspections

  • Imported products and permittee responsibilities
  • U.S. veterinary biologics establishment license requirements
    • facility documentation, blueprints, plot plans, legends and addenda, personnel qualifications and experience
  • Facility inspections by CVB inspection and compliance

Q&A and close of forum

Presenter

Donna Mattson

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.

Book now

2 May 2019
2 May 2019 Cavendish Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

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