When: 20–21 April 2027
Where: Online
Start time day 1: 09:00 | 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 expert presenters for this course will be announced soon
Pricing
TOPRA member: £1,250 + VAT
Non-member: £1,750 + VAT
Join TOPRA and enjoy the member rate on every training course you book. Become a member >
Members working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets and MSEs can access further discounted rates. Please email
meetings@topra.org before booking.
I
mportant Notice On VAT
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Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.