When: 8 - 9 July 2025
Time: 08:30 - 18:00 BST
Where: TOPRA 3rd Floor, City Reach. 5-6 Greenwich View Place, London, E14 9NN
Also available as an online course, please click here for the online registration option
Course overview
The course is intended to bring the theory and practice of running and working with the EU procedures to life, illustrated with real life examples and case studies.
The course will also cover:
- Developing your global filing strategy
- Decentralised and Mutual Recognition procedures
- Centralised procedure
- Key EU regional considerations
- Competent Authority perspective
Benefits to delegates
- Meet and learn from experts in the field from both industry and agency
- Learn by doing - participate in case studies and interactive sessions
- Build a network to support the rest of your career
- Gain a firm understanding of the European Regulatory System for medicinal products, developing strategies and HTA
- Get practical application of European procedures – an increased focus on the practicalities
CPD: This course provides 17 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
A draft programme is available here.
Presenters
Presenters for this course include:
- Matthew Sardo, Sardo Trading Limited
- Bob Clay, Highbury Regulatory Science Limited
- Kora Doorduyn-van der Stoop, Medicines Evaluation Board (MEB)
- Stephen Smith, MESAVS Regulatory Solutions Ltd
- Jayne Hunt, Arriello S.R.O
- Eesha Vyas, GSK
- Alex Yates, Bicycle Therapeutics
- Paul Nitschmann, Intercept Pharmaceuticals
Suitable for
- Those who wish to progress from the introductory course level
- More experienced professionals changing area or moving into European submissions
- Allied professionals for example: Clinical professionals who want to understand the regulatory procedures better and project managers who want to understand the regulatory procedures better.
Pricing
Simply log in or create an account and register below.
| Type |
Member |
Non-member |
| Standard |
£1,050 +VAT |
£1,250 +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
|
£787.50 +VAT
|
£937.50 +VAT |
Those working for charities, patient groups or in full-time education
|
£525 +VAT |
£625 +VAT |
*VAT, if 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
Next steps