When: 10 November 2026
Where: Online
Time: 09:30 -15:30 GMT | 10:30 -16:30 CET
CPD: 8 CPD hours upon successful completion
Who should attend?
This course is ideal for:
• Regulatory affairs professionals who are interested in biotechnology and innovative medicines
• Those who are working for organisations that are targeting medicine innovation
What you'll learn
By completing this course, you will be able to:
- Acquire key information about regulatory processes that support early access to innovative medicines
- Apply practical guidance for preparing and managing orphan drug submissions
- Gain first-hand insights on how to optimise opportunities under orphan drug regulations
- Navigate Orphan Medicinal Product legislation and its requirements
- Gain insights into both EU and global approaches to orphan drug designation
Course overview
This course offers a comprehensive understanding of the opportunities and challenges within orphan drug regulations, from both an EU and global perspective. It covers key topics such as orphan medicinal product legislation and the process of obtaining and maintaining orphan drug designation, providing practical guidance to support the development of medicines for rare diseases.
Course presenters
The expert presenters for this course are:
- Evgenia Mengou - Director, EV Pharma Solutions
- João Duarte -Vice President, Head of Global Regulatory Affairs Excellence, Ipsen
- Akiko Tagawa - Regulatory Senior Program Director, F. Hoffmann-La Roche Ltd
- Neama Baho - Regulatory Affairs Consultant, Regulatory and Resourcing
- Adriaan Fruijtier - Regulatory Affairs Consultant, CATS Consultants GmbH
- Joanne Allen - Senior Director & Group Manager, AstraZeneca
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Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£650.00 + VAT* |
Standard Price
Non-member |
£910.00 + VAT* |
Those working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets, and MSEs (Micro and Small Enterprises) can also access discounted rates by becoming a TOPRA member. For more information about the discounts available, please email meetings@topra.org before making your booking.
Important Notice On VAT
In compliance with regulations, a *20% VAT will be charged to attendees only where applicable. If you have a VAT number or if the company or organisation you are affiliated with has a VAT number or equivalent please ensure it is visible on your profile. If your VAT number is not visible on your profile, please email finance@topra.org to have it updated. If you do not have a VAT number, there is no action required — VAT will be applied accordingly during the registration process. Please observe that the VAT number needs to be valid.
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Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.
PLEASE ENSURE YOU SELECT THE PAY LATER OPTION AT CHECKOUT