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Management Forum

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.

18-19 Jan 2023
+ 2 more dates

Need help?  Enrol or reserve

  • Format: Live online
  • CPD: 6 hours for your records
  • Certificate of completion

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

Enrol or reserve

The Registration of Veterinary Vaccines in the USA and Canada course will cover:

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)

Enrol or reserve

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.

More details

Book Registration of Veterinary Vaccines in the USA and Canada Live online training

NEW higher discounts for multiple bookings - 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*

Please contact us for pricing if you are interested in booking 5 or more delegates

18-19 Jan 2023

Live online

13:00-17:00 UK (London) (UTC+00)
14:00-18:00 Paris (UTC+01)
08:00-12:00 New York (UTC-05)
Course code 12726

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 14 Dec

View basket 

 
Not ready to book yet?

for 7 days, no obligation

4-5 May 2023

Live online

13:00-17:00 UK (London) (UTC+01)
14:00-18:00 Paris (UTC+02)
08:00-12:00 New York (UTC-04)
Course code 12727

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 30 Mar

View basket 

 
Not ready to book yet?

for 7 days, no obligation

13-14 Sep 2023

Live online

13:00-17:00 UK (London) (UTC+01)
14:00-18:00 Paris (UTC+02)
08:00-12:00 New York (UTC-04)
Course code 12728

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 09 Aug

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Germany

  • BIVRC GmbH & Co KG
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Vetmedica GmbH
  • IDT Biologika
  • IDT Biologika GmbH
  • Klifovet AG

United Kingdom

  • Benchmark Animal Health Ltd
  • Eco Animal Health Ltd
  • IAHJ - International Animal Health Journal
  • TBC

Belgium

  • Aratana Therapeutics NV
  • ViroVet BVBA
  • ViroVet NV

France

  • Boehringer Ingelheim
  • CEVA Sante Animale

Canada

  • EVAH CORP.

Israel

  • Phibro Animal Health

Norway

  • PHARMAQ AS

Switzerland

  • Novartis, Centre de Recherche

Enrol or reserve

Run Registration of Veterinary Vaccines in the USA and Canada Live online for your team

1 day

Typical duration

Pricing from:

  • GBP 450
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy