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Managing Variations Effectively




London, UK


07 Jun 2018

Reference No: T1803285 - TOP

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Event Description

Course Outline:

Variations are core to lifecycle maintenance and vital to ensure a product registration is up to date. This practical CRED workshop will explain the principles of the EU Variations Regulation as well as cover intricacies of procedures for grouping and worksharing, and use examples to illustrate the guidelines on categorisation
This course will cover:

  • Key aspects for successful variation applications
  • Categorisation of variations (IAin, IA, IB and II)
  • Quality,safety/efficacy and pharmacovigilance variations
  • Feedback on common pitfalls experienced with applications
  • Best practice for national and MRP/DCP/centralised applications 

When & Where:

7 June 2018

TOPRA, 6th Floor
3 Harbour Exchange
South Quay
London, E14 9GE


TOPRA Member: £550 plus 20% VAT
Non-TOPRA Member: £675 plus 20% VAT


Applicant Requirements
  • Less experienced regulatory professional who requires comprehensive information on this subject
  • Experienced professional who is a newcomer to this subject
  • Those who wishes to update their knowledge on this subject
Reference No: T1803285 - 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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