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.

: 25 June 2020
Time: 09:00 - 17:00 BST (GMT+1)

TOPRA is committed to continuing to support the education of regulatory professionals in this unprecedented situation. However, in light of recent developments and the advice from health authorities, we have made the decision for this course to go ahead as an interactive online course on the same date with many opportunities for questions to the speakers. All delegates already booked on the course will be individually contacted and if you require further information please

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. Although orphan drugs are designed to deliver new solutions for the treatment of rare diseases they are forecast to account for 55% of the European pipeline by 2022*. (*EvaluatePharma Orphan Drug Report 2017)

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.


Download a copy of the programme here.

Suitable for

  • Regulatory Affairs Professionals who are interested in biotechnology and innovative medicines 
  • Those who are working for organisations that are targeting medicine innovation


How to register

Simply log in or create an account and register below.


Course *fees:
Type Member Non-member 
Standard    £550+VAT  £675+VAT

Discounted places
A limited number of discounted places are available at the rates below.
Please email us at for a discount code before making your booking.

Those working for regulatory agencies, government agencies or academic institutions 
Those working for charities, patient groups or in full-time education
 £275+VAT  £337.50+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

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