When: 8 - 9 July 2025
Where: TOPRA 3rd Floor, City Reach, 5-6 Greenwich View Place, London, E14 9NN
Time: 08:30 - 18:00 BST
This course is also available to take part in online.
Suitable for
This course is designed for those:
- 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.
Course information
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
- Kora Doorduyn-van der Stoop, Chair person CMDh/ EU representative at the MEB, Medicines Evaluation Board (MEB)
- Jayne Hunt, Experienced Regulatory Affairs Professional
- Matthew Sardo, Sardo Trading Limited
- Melissa Smart, Global Labeling Product and Initiative Leader - Director, Johnson & Johnson
- Stephen Smith, MESAVS Regulatory Solutions Ltd
- Alex Yates, VP Regulatory Affairs & Development Quality, Bicycle Therapeutics
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.