Registration of Veterinary Vaccines in the USA and Canada (London, United Kingdom - October 18, 2018)

  • ID: 4435606
  • Conference
  • Location: London, United Kingdom
  • 1 Day
  • Management Forum
  • Conference Dates: October 18, 2018
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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.

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.

Benefits in attending:

  • Understand the phased-submission process for vaccinelicensing
  • Learn the format and content specifications for the required dossier components
  • Review the USDA regulations (9 CFR) and guidance (memoranda, notices, supplemental information formats (SIF), supplemental assay methods (SAM)
  • Compare the regulatory fee structures (no fees for USDA-licensing, minimal fees for Canadian licensing of biologics)
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09.30             Welcome and introduction

09.45  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

11.15                           Refreshments

11.30    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

12.45               Lunch

13.45     Transferability of EU dossiers for USDA submission
Compare challenge and field study requirements
USDA dossier for EMA submission

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

15.15               Refreshments

15.30     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

17.00                    Q&A and close of forum

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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.

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ADDRESS

London
United Kingdom

Venue to be announced shortly.

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