When: 26 November 2024
Where: Online
Time: 08:35-13:45 GMT | 09:35-14:45 CET
Course overview
This CRED 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 provide a global perspective as well
"Excellent overview of the orphan framework in key markets, either as initial information or to consolidate knowledge. Also great opportunity for exchange among peers, share experience and brainstorm around most common challenges" – 2021 delegate
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 copy the course programme here.
Presenters
Presenters include:
Suitable for
- Regulatory affairs professionals who are interested in biotechnology and innovative medicines
- Those who are working for organisations that are targeting medicine innovation
Pricing
Course *fees:
| Type |
Member |
Non-member |
| Standard |
£570+VAT |
£695+VAT |
Add membership to your booking to access the members' discount.
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
|
£427.50+VAT
|
£521.25+VAT |
Those working for charities, patient groups or in full-time education
|
£285+VAT |
£347.50+VAT |
|
*VAT, if applicable, is charged at the rate of 19%
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions