CRED Regulatory Update: Veterinary Variations in the EU

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.

When
: 28 November 2024 
Where: Online 
Time: 09:00-16:00 BST



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


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

Programme

Click here for a copy of the last course programme.

Presenters

Past presenters for this course have included:

  • Patrizia Oelker - Boehringer Ingelheim
  • Melanie Anderson - Knoell (UK)
  • Luisa Pachés - Knoell (UK)

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 

Pricing  

Course *fees:
Type Member Non-member 
Standard    £570+VAT  £695+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 
 £427.50+VAT
£521.25+VAT 
Those working for charities, patient groups or in full-time education
 £285+VAT  £347.50+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

When
28/11/2024 09:00 - 16:00
Where
ONLINE
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Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

Thursday, 28 November 2024

Description
Time
28/11/2024 - 29/11/2024
28/11/2024

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