Achieving Orphan Designation (ODD) - Meeting the unmet need

Achieving Orphan Designation (ODD) - Meeting the unmet need

Achieving Orphan Drug Designation is a significant step enabling your product to be licensed faster, in a cost-efficient manner, and achieve market exclusivity for 10 years.

Join this 1-hour webinar where you will gain a practical overview of the steps to achieve orphan status including:

  • Review of the Orphan Drug Designation eligibility criteria, including a registered medicine with a new ‘orphan indication’
  • An overview of Orphan Drug Designation incentives, such as tax, marketing approval and market exclusivity
  • Practical application, process and insights
  • EU & FDA requirements and assessing the differences

For more information on rare diseases, take a look at our rare diseases page.

We offer lots of other great webinars, like our webinar on ‘Rare Disease & Orphan Drug Development – Cost-efficient trial design to minimise cash burn‘.