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Registration of Veterinary Vaccines in the USA and Canada Training Course
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.
14-15 Sep 2022
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
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
USDA Regulatory Jurisdiction
- Overview what fits into USDA, FDA or EPA
- Why does it matter who regulates a product?
- How is it determined which organization regulates a product?
- Project planning and timescales
Development plans to guide USDA Licensing projects
- Why start with a development plan?
- What should be included in the Development Plan?
- How does this guide the entire project?
Import and Transport Permits
- For Research and Development
- For Sale and Distribution
- 103.3 movement
Master Seed, Master Cell Stocks and Master Sequences
- Required/recommended testing
- Additional USDA requirements
- Best practices
Required Studies
- Efficacy
- Safety
- Field Safety
- Back Passage / Reversion to Virulence (BPRTV)
Outline of Production
- Required Sections
- Difference between Outline and production documents
Labeling and Packaging
- Single Tier vs old four tier wording
- Current labelling requirements
- Common issues with labelling
Establishing a Licensed Facility
- Facility Document basics
- Common issues with Facility Documents
USDA Facility Inspections
- In person
- Virtual
Autogenous vaccines
- What are autogenous vaccines and how are they different from ‘regular’ vaccines?
- Common questions about autogenous vaccines
USDA Web Portal
The Role of quality in a USDA regulated environment
- Standard operating procedures (SOPs) writing, use and review
- QA vs QC (USDA’s expectations)
Presenter
Nick Wills (More...)
Nick Wills is a regulatory affairs advisor with over 10 years of experience in Veterinary Biologics development in a regulatory and quality assurance capacity. In his current position as an Advisor for Veterinary Product Development at knoell Animal Health, Nick assists clients with a wide range of regulatory projects including licensing of new products, preparation of regulatory documents and inspection readiness. Nick’s prior experiences within a CRO/CMO, as well as within large veterinary biologics company allow him to bring USDA regulated expertise, ranging from licensing new products and preparing facilities for inspections to solving regulatory issues for existing products. Nick also has significant experience with labeling and registration of US products in foreign countries. Nick particularly enjoys the complicated problem solving and scientific elements of regulatory affairs work.
Book now
Book now
NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
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14-15 Sep 2022 Live webinar 13:00-17:00 UK (London) |
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14-15 Sep 2022 Live webinar 13:00-17:00 UK (London) |
GBP 599 499 EUR 859 719 USD 970 814 Until 10 Aug* |
Enrol now
to attend Live webinar |
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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. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.