As you want to start regulatory interactions in Europe for an orphan drug, you may face many challenges or miss game changing opportunities.
Indeed, the European Medicines Agency (EMA) provides specific incentives to companies who are granted ODD for their product as well as additional financial advantage to companies registered as SME (special status).
During this process you may face challenges especially if you are not familiar with the EU health authorities, EU accelerated pathways or existing incentives. Also if you have very limited or no resources/expertise in Europe and that you need to focus Regulatory Affairs Team on development activities.
Our experts will help you to understand how to optimize the development of your orphan products in Europe »
Learning objectives :
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