CRED Managing Variations Effectively

CRED Managing Variations Effectively
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. This workshop also will cover intricacies of procedures for grouping and worksharing, and use examples to illustrate the guidelines on categorisation.

When: 7 June 2018 
Where: TOPRA, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE 




What is it?
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.

Who is it for?
  • 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


What will I learn?
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 

Download the course programme

CPD: 8


How do I apply? 
Simply login or create an account and register below. 

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 
  £412.50+VAT
  £506.25+VAT
Those working for charities, patient groups or are in full-time education
  £275+VAT
  £337.50+VAT

 

Terms and conditions 
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.
When
07/06/2018
Where
TOPRA Ltd 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
Online registration not available.
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NOTE
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

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