CRED Optimising Regulatory Strategies for Orphan Drugs

CRED Optimising Regulatory Strategies for Orphan Drugs
There are regulatory processes and procedures to expedite approval and access, and to help support the development of medicines for the treatment of rare diseases. This course will provide key information about those regulatory processes and first-hand insights on how to get the best out of them.

When: 30 October 2025
Where: TOPRA 3rd Floor, City Reach. 5-6 Greenwich View Place, London, E14 9NN 
Time: 08:30 GMT | 09:30 CET

Also available as a online course, please click here for the online registration option.

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

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 

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    £620 +VAT  £720 +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 
  £465 +VAT
  £540 +VAT 
Those working for charities, patient groups or in full-time education
  £310 +VAT  £360 +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
When
30/10/2025 09:00 - 17:00
Where
TOPRA 3rd Floor 6th Floor 5-6 Greenwich View Place London E14 9NN UNITED KINGDOM
Sign in or create an account to register Last day to register is 29/10/2025
My registration status: Not registered
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Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

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