TEST CRED Regulatory Update: Veterinary Variations in the EU

TEST CRED Regulatory Update: Veterinary Variations in the EU
This is a comprehensive overview of how to prepare and submit variations to VMP marketing authorisations. It provides an update on the latest changes and advice on best practice for experienced regulatory professionals.

: 28 November 2024 
Where: Online 

Course overview

The course will cover:

  • The procedures and latest developments on grouping, work-sharing and the guidelines on categorisation
  • The use of Type IA ‘annual reports’ and the involvement of CMD(v)
  • The impact of development relating to the quality dossier
  • The safety, efficacy and development to Pharmacovigilance system 

Benefits to delegates

  • Understand how variation procedures operate for VMPs, how best to do group changes and when work-sharing can be applied
  • Understand how to classify a variation and prepare an application for submission
  • Understand the different approaches to extension variations and how variation referral procedures operate
  • Understand the strategic aspects of variations, how to balance the time until approval against the cost and resources
  • Learn by doing - participate in case studies and interactive sessions 
  • Build a network to support the rest of your career
  • Meet and learn from experts in the field 
  • Take a course developed by professionals, for professionals - with a proven track record

This course provides 8 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.


Click here for a copy of the last course programme.


Past presenters for this course have included:

  • Beate Gasser - Austrian Federal Office for Safety in Health Care - BASG (Austria)
  • Wiebke Godow - Federal Office of Consumer Protection and Food Safety - BVL (Germany)
  • Gavin Hall - VMD
  • Luisa Pachés - Cyton Biosciences (UK)
  • Kevin Yount - Bayer Animal Health (Germany)

Suitable for

  • Those who are working for organisations operating within the European Union with marketing authorisation for veterinary products
  • Those from human regulatory affairs, who want an understanding in how variations are managed in the veterinary sector
  • New regulatory personnel 


Course *fees:
Type Member Non-member 
Standard    £550+VAT  £675+VAT

Discounted places
A limited number of discounted places are available at the rates below.
Please email us at meetings@topra.org for a discount code before making your booking.

Those working for regulatory agencies, government agencies or academic institutions 
Those working for charities, patient groups or in full-time education
 £275+VAT  £337.50+VAT

*VAT, if applicable, is charged at the rate of 20%

Terms and conditions

By booking a place on this course you are agreeing to the training terms and conditions

28/11/2024 09:00 - 29/11/2024 17:00
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Thursday, 28 November 2024

28/11/2024 - 29/11/2024

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