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Overcoming the Challenges of Launching an Early Access Program in Europe

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"Overcoming the Challenges of Launching an Early Access Program in Europe"

Learn how to navigate the complex European landscape to enable early access to rare and orphan drugs.

Early access programs in Europe are an attractive option for US companies. 

For patients ineligible for a clinical trial, they offer access to potentially lifesaving drugs. For biotech firms, they provide valuable, real-world data, plus the opportunity to build relationships with prescribers and patient advocacy groups.

But there are challenges. Not least the multiple complex regulations involved in gaining approval and different healthcare systems across many member states.

Download this guide to learn how to navigate the complex European landscape, including takeaways on:        

●    The potential challenges 
●    What your strategic aims should be 
●    Risk and reward
●    A guidance to access and regulation
●    The role of the European Medicines Agency


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