DUBLIN--(BUSINESS WIRE)--The "Registration of Veterinary Vaccines in the USA and Canada" conference has been added to ResearchAndMarkets.com's offering.
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.
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
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
- Code of Federal Regulations, Title 9 (9 CFR)
- 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 inspections by CVB Inspection and Compliance
For more information about this conference visit https://www.researchandmarkets.com/r/29eeqa