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Orphan Drugs: Optimising Regulatory Strategies 

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
: 25 June 2020
Where: TOPRA. 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Time: 09:00 – 17:00 BST (GMT+1)

Orphan Drugs Regulatory Stratgeies: 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.

Programme

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
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