Orphan Drug Designation: Meeting the Unmet Need in Rare Diseases, New Webinar Hosted by Xtalks

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.

Xtalks Life Science Webinars

In a live session taking place on Thursday, April 26, 2018 at 14.00h BST/UK (9 a.m. EDT) experts from Simbec-Orion Chirag Patel, Director of Regulatory Affairs & Technical Writing and Sadiq Lutfi, Regulatory Affairs Manager, along with featured speaker Art Gertel, President and Principal Consultant at MedSciCom, LLC, will discuss orphan drug designation, its importance and how to achieve orphan drug status faster and more efficiently.

Join this 1-hour webinar to 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 about this free event visit: Orphan Drug Designation: Meeting the Unmet Need in Rare Diseases.


Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com.

For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar.


Nima Rajan

Tel: +1 (416) 977-6555 ext 352

Email: nrajan@xtalks.com

Source: Xtalks

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