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 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.
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)
- Welcome and introduction
- 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
For more information about this conference visit https://www.researchandmarkets.com/research/4htdfn/1_day_course?w=4