Module 1 2021

30/06/2021

• What is the regulatory context for orphan products • Defining an orphan condition Learning Outcomes - Recap

• What incentives does an orphan designation provide and how can these beneficial during development and post-approval • What to consider when to apply and how to apply • An orphan status is not infinite • The importance of showing significant benefit and what doe significant benefit mean • Stakeholders to consider during your development program in a global environment • Challenges and opportunities during the orphan

The Organisation for Professionals in Regulatory Affairs

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Managing Consultant, ProPharma Group The Netherlands email: liesbeth.hof@propharmagroup.com Liesbeth Hof

The Organisation for Professionals in Regulatory Affairs

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