Navigating the Regulatory Complexities of Orphan Drugs: Know the unwritten rules of designations and what’s next

Nov 02, 2017

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With the FDA’s recent 90-day orphan drug designation review commitment and rare disease research initiatives popping up across Europe and other regions, you have no time to waste in orphan drug development.

But, you won’t get far without understanding the unwritten rules.  A knowledgeable partner from the beginning can help you avoid unnecessary regulatory delays and costs and help you prepare for other special designations and what’s next. In the case of orphan drugs, the relatively small investment on the front end, makes the difference in your orphan drug’s success.



Tim Coté, MD, Vice President, Global Regulatory Affairs, Coté Orphan, LLC, a QuintilesIMS Company

Allison Gillespie, Senior Director and Head of Europe, Global Regulatory Affairs, QuintilesIMS


Date and Time:

Live: Thursday, Nov.  2, 2017 |  11 am EDT

After the final airing of the webcast Nov. 2, 2017 it will be available on demand until Nov. 2, 2018. 

Sponsor: QuintilesIMS

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