2 Day Virtual Registration of Veterinary Vaccines in the USA and Canada Training Course (September 11-12, 2024)

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Nov 27, 2023, 21:30 ET

DUBLIN, Nov. 27, 2023 /PRNewswire/ -- The "Registration of Veterinary Vaccines in the USA and Canada Training Course" conference has been added to ResearchAndMarkets.com's offering.

The programme will address the transferability of EU dossiers for USDA submission, which will be beneficial in planning your regulatory strategy.

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 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.

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

Certification:

CPD: 6 hours for your records
Certificate of completion

Who Should Attend:

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

Agenda:

Day 1

USDA Regulatory Jurisdiction

Overview of 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)

Day 2

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)

Speakers:

Nick Wills
knoell

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.

For more information about this conference visit https://www.researchandmarkets.com/r/w93gt6

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