When: 27-28 May 2025
Where: Lincoln Plaza London Hotel, 2 Lincoln Plaza, Canary Wharf, London, E14 9BD
Start time day 1: 09:00 BST | End time day 2: 16:30 BST
This course is also available to take part in online.
Suitable for
This course is designed for those:
- Less experienced regulatory affairs professionals;
- Those who are going into the area of processing/preparing/submitting variations;
- Regulatory professionals who would like a refresher in the subject area.
Course information
This practical course will explain the principles of the EU variations regulation and will cover the intricacies of grouping and work-sharing procedures, using examples to illustrate the categorisation guidelines. Other critical actions for effective lifecycle management will be discussed.
Managing lifecycle topics will include:
- Post-approval commitments
- Variations
- Renewals and PSUR
- PRAC/CMDh recommendations
- Regulatory activities related to change in marketing status
- plus other topics
Variations topics will include:
- Overview of the key principles of Regulations (712/2012 amending 1234/2008) and variation guideline
- Variation Types, data requirements
- Experience sharing/Practical issues for submissions with focus on centralised procedure
- Future considerations: ICH Q12, Brexit etc
- Variation procedures and their impact on strategy and implementation.
Benefits to delegates
- Meet and learn from experts in the field
- Learn by doing- participate in case studies and interactive sessions
- Build a network to support the rest of your career
- Take a course designed by professionals for professionals with a proven track record
- Get pointers about how to strategize the submission of variations to save money and avoid invalidation.
- Gain an up-to-date overview of variation classification and procedures in the EU.
CPD: This course provides 14.5 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
Download a copy of the draft programme here.
Course Leader
Presenters
Presenters include:
- Matthew Camilleri, Head of Regulatory Projects, Malta Medicines Authority
- Rachel Harte, Associate Director Regulatory Affairs, CAI UK
- Richard Keane, Senior Director, Head of Global Regulatory CMC Commercial Products, Biogen
- Yevheniia Prysiazhna, Regulatory Affairs Manager, G&L Scientific
- Marta Viras, Associate Director Regulatory Affairs, PPD
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,050.00 + VAT* |
Standard Price
Non-member |
£1,250.00 + VAT* |
Save on the full cost of membership and £180 on the price of your training
course when you add TOPRA membership to your booking (membership fees are exempt from VAT).
*VAT, where applicable, is charged at the rate of 20%.
| Discounted training course registration fees |
| Event Registration Type |
Price (GBP) |
Government or academic rates
TOPRA Member
|
£787.50 + VAT* |
Government or academic rates
Non-member
|
£937.50 + VAT* |
Charities, patient groups, full-time education rates
TOPRA Member |
£525.00 + VAT* |
Charities, patient groups, full-time education rates
Non-member
|
£625.00 + VAT* |
Places are also available for those in low-income countries as defined by the World Bank.
*VAT, where applicable, is charged at the rate of 20%.
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions.