We are pleased to announce that we will be joining Virtual Summit “Rare Disease Therapies Development” as speakers. This summit provides a unique opportunity to pharma and biotech companies to share non-IP knowledge and best practices.
Join our speakers Xavier Prugnard and Daniel Garcia for their presentation “Orphan Drug Designation EU and US, regulatory strategy, incentives and key points to consider”.
This presentation will explore the opportunities and challenges of the Orphan Drug Designations in US and EU with a view to informing regulatory strategies for the successful registration of rare disease products and enable faster access to treatments for patients. Participants will gain valuable insights into when and how to consider applying for Orphan Drug Designation (eligibility criteria, timelines, benefits) to optimize the clinical development and registration of your drug in the US and EU markets.
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