Optimising Regulatory Strategies for Orphan Drugs

Optimising Regulatory Strategies for Orphan Drugs
There are regulatory processes and procedures to expedite approval and access, and help support the development of medicines for the therapy 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.

: 9 April 2019
Where: TOPRA. 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Time: 09.00 - 17.00

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 therapy of rare diseases they are forecast to account for 55% of the European pipeline by 2022*. (*EvaluatePharma Orphan Drug Report 2017)

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.


The latest course programme can be downloaded 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


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 meetings@topra.org 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%

TOPRA 6th Floor, 3 Harbour Exchange London E14 9GE UNITED KINGDOM
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