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Regulatory Update: Veterinary Variations in the EU




London, United Kingdom


17 Oct 2019

Reference No: T1907364-TOP

Apply for this event

Key points about this Training Event

  • 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 and understand the different approaches to extension variations and how variation referral procedures operate
  • Participate in case studies and interactive sessions whilst building a network to support the rest of your career
  • Meet and learn from experts in the field in attending a course developed by professionals, for professionals - with a proven track record
Event Description

Course Outline:

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

When & Where?

17 October 2019 09:00 - 17:00

TOPRA Office
3 Harbour Exchange
E14 9GE


TOPRA Members £550.00 plus 20% VAT
TOPRA Non Members £675.00 plus 20% VAT

Applicant Requirements
  • 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
Reference No: T1907364-TOP
TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs.
We work with our members internationally to enable and promote excellence across the healthcare regulatory profession.


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