When: 30 October 2025
Where: TOPRA 3rd Floor, City Reach, 5 Greenwich View Place, London, E14 9NN
Time: 08:30 GMT | 09:30 CET
This course is also available to attend in person.
Suitable for
This course is designed for those:
- Regulatory affairs professionals who are interested in biotechnology and innovative medicines;
- Those who are working for organisations that are targeting medicine innovation.
Course information
This course will provide a comprehensive understanding of the opportunities and challenges offered by orphan drug regulations and practical advice on how to navigate them.
This course will cover:
- Orphan Medicinal Product Legislation
- Obtaining and maintaining orphan drug designation
- Primarily focused on EU but will also provide a global perspective
Benefits to delegates
- Acquire key information about regulatory processes intended to expedite early access to innovative medicines
- Get practical advice on how to prepare and manage orphan submissions
- Get first-hand insights on how to get the best from orphan drug regulations
- Meet and learn from experts in the field and share the experiences of fellow delegates
- 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
CPD: This course provides 8 CPD hours upon successful completion.
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
Download a draft copy of course programme here.
Presenters
Presenters include:
- Tara Hutton, Director, Biogen
- Adriaan Fruijtier, Director Regulatory Affairs, CATS Consultants GmbH
- Jennifer Svec, Principal Regulatory Consultant, Director, The Reg Group Pty Ltd
- Joanna Allen, Biogen
- Ana Maria Buehlmann, Regulatory Program Director,Roche
- Joao Duarte, Vice President, Head of Global Regulatory Affairs Excellence, Ipsen
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£620.00 + VAT* |
Standard Price
Non-member |
£720.00 + VAT* |
Include membership with your booking below to unlock members' discounts. By becoming a TOPRA member before September 30 2025, you'll receive an additional 3 months of membership for just £20 (subject to terms and conditions). Join now to access exclusive member content and enjoy discounts on courses, including this year and next year's Annual Symposium. Please be aware that 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
|
£465.00 + VAT* |
Government or academic rates
Non-member
|
£540.00 + VAT* |
Charities, patient groups, full-time education rates
TOPRA Member |
£310.00 + VAT* |
Charities, patient groups, full-time education rates
Non-member
|
£360.00 + 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.