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QDossier Presenting on Regulatory Strategies for Orphan Drugs

November 22

This interactive course will shed light on the orphan medicinal product legislation in the EU and the US. It will guide you through the application and procedure for obtaining orphan drug designation. The event will shed light on the strategic considerations of when to apply for orphan designation and to which agency. There will be a case study session so that you gain practical skills on how to prepare and manage orphan drug submissions.
The course is covered in four modules:
Module 1 – Orphan Medicinal Product legislation
• Overview of the legislation in the EU, US, and Japan
• What the Regulations cover and why, what they try to protect
• Benefits of Orphan Drug Designation
• Key Considerations
o Country Submissions
o Differences of Orphan versus non-orphan
o Paediatric Conditions
Module 2– Obtaining Orphan Drug Designation
• Orphan drug designation in the EU
o Application
o Procedure
• Similarities and differences with the US
o Application, procedure, and incentives
• Global Issues around Rare Disease
• Strategic Considerations
• Case Study
Module 3 – Maintenance of Orphan Drug Designation
• How to maintain
• Maintenance during MAA and NDA
• Assessment and Case Study
Module 4 – Orphan Drug Designation
• Global perspective for Russia, China, etc

Speaker: Marloes van der Geer

Find more information here.




Management Forum
+44 (0)20 7749 4730