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Registration of Veterinary Vaccines in the USA and Canada Training Course: live webinar

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.

11 Mar 2021

& 12 Mar 2021

Book now

Details

Course Overview

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:

  • Gain a comprehensive insight into the difference of approach to licensing in the USDA/CFIA vs EU
  • Understand the phased-submission process for vaccine licensing
  • Learn the format and content specifications for the required dossier components
  • Review the USDA regulations (9 CFR) and guidance – memoranda, notices, supplemental information formats (SIFs), supplemental assay methods (SAMs)
  • Compare the regulatory fee structures for the USA and Canada
  • Discuss the transferability of EU dossiers for USDA submission

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Who should attend?

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:

  • Regulatory affairs professionals
  • Registration managers
  • Global vaccines regulatory associates
  • Programme managers for biologics
  • Business development directors

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 US Veterinary Biologics Product License

  • Categories of licenses issued by USDA CVB
  • Basic licence requirements
  • 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

Recent changes to the regulations and guidance

Permits, establishment licence and inspections

  • Imported products and permittee responsibilities
  • US Veterinary Biologics Establishment License requirements

- Facility documentation, blueprints, plot plans, legends and addenda, personnel qualifications and experience

  • Facility inspections by CVB Inspection and Compliance

Presenter

Donna Mattson (More...)

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

Book now

11 Mar 2021
Live webinar
11 Mar 2021
Live webinar
GBP 499.00
EUR 719.00
USD 814.00
Until 28 Jan 21*
Enrol now
to attend
Live webinar
12 Mar 2021
Face-to-face, (venue not yet confirmed)
12 Mar 2021
Face-to-face
(venue not yet confirmed)
GBP 599.00
EUR 839.00
USD 934.00
Until 29 Jan 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 1 day of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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  • Boehringer Ingelheim
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  • CEVA SANTE ANIMALE
  • Eco Animal Health Ltd
  • IDT Biologika GmbH
  • Klifovet AG
  • Novartis, Centre de Recherche
  • PHARMAQ AS
  • TBC
  • ViroVet BVBA
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