CRED Variations

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





ONLINE REGISTRATION IS NOW CLOSED FOR THIS MEETING
IF YOU ARE INTERESTED IN REGISTERING, PLEASE CONTACT: MEETINGS@TOPRA.ORG



This course will include:

  • Advice on key aspects for successful variation applications
  • Categorisation of variations (IAin, IA, IB and II)
  • Quality,safety/efficacy and pharmacovigilance variations
  • Share feedback from MHRA on common pitfalls experienced with applications
  • Chance to hear directly from the EMA
  • Best practice for national and MRP/DCP/centralised applications
  • Practical experiences shared.
  • In addition, all the key principles of the preparation and submission of variations in the EU (for products approved via Centralised, Mutual Recognition and National procedures) will be covered.
  • The workshop will include presentations, a case study, debate and discussion with key industry experts and agency speakers.

 

Testimonials

“Case study and discussions were immensely helpful”

“Presentations were concise and useful – examples were helpful and put guidelines in perspective”

CPD

This course offers 6 CPD hours for successful completion, to learn about why CPD is important visit the Lifelong Learning page.


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.

Course price (to register, please log in or create an account): 

Member:  £550+VAT          Non-member:  £675+VAT 


Those working for regulatory agencies or government agencies or academic institutions:  

Member:  £412.50+VAT           Non Member:  £506.25+VAT 


Those working for charities, patient groups or in full time education: 

Member:  £275+VAT           Non Member:  £337.50+VAT 


If you book on the CRED Variations and CRED SmPC course you are entitled to a 15% discount, please contact the professional development team for the discount code.

For a discount please contact the professional development team for the code (please note the number of discounted places may be limited.)


- Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable).

 
When
07/06/2017
Where
CRED Variations Doubletree By Hilton London Victoria 2 Bridge Place, Victoria London SW1V 1QA UNITED KINGDOM
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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

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