This course is also available to attend in-person.
When: 12-13 May 2026
Where: Online
Start time day 1: 09:00 BST | End time day 2: 16:30 BST
CPD: 14.5 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Regulatory professionals who are new to preparing, processing, or submitting variations
- Regulatory professionals who would like a refresher on EU variations and lifecycle management
What you'll learn
By completing this course, you will be able to:
- Gain an up-to-date understanding of EU variation classifications and procedures
- Strategise variation submissions to reduce unnecessary costs and avoid invalidations
- Build a network of peers and experts to support the rest of your career
Managing lifecycle topics will include:
- Post-approval commitments
- Variations
- Renewals and PSUR
- PRAC/CMDh recommendations
- Regulatory activities related to change in marketing status
Variation-specific topics will include:
- Key principles of Regulations 712/2012 and 1234/2008, and the Variations Guideline
- Variation types and associated data requirements
- Practical insights and experience sharing, with a focus on centralised submissions
- Future considerations such as ICH Q12 and Brexit
- How variation procedures influence regulatory strategy and implementation
Course overview
This practical course provides a clear introduction to the principles of the EU Variations Regulation. You will explore the complexities of grouping and work-sharing procedures and learn how to apply categorisation guidelines through real-world examples. The programme also examines other essential components of lifecycle management, giving you a comprehensive foundation for managing post-authorisation activities effectively.
Course presenters
The other expert presenters for this course are:
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,250.00 + VAT* |
Standard Price
Non-member |
£1,750.00 + VAT* |
Those working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets, and MSEs (Micro and Small Enterprises) can also access discounted rates by becoming a TOPRA member. For more information about the discounts available, please email meetings@topra.org before making your booking.
Important Notice On VAT
In compliance with regulations, a *20% VAT will be charged to attendees only where applicable. If you have a VAT number or if the company or organisation you are affiliated with has a VAT number or equivalent please ensure it is visible on your profile. If your VAT number is not visible on your profile, please email finance@topra.org to have it updated. If you do not have a VAT number, there is no action required — VAT will be applied accordingly during the registration process. Please observe that the VAT number needs to be valid.
Click here to check and validate your VAT number.
For EU countries; if you are unsure of the VAT number, click here to check and validate your VAT number.
Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.