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US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases
Session Chair(s)
Imran Shah
SVP & Head, Global Regulatory, R&D Quality and Safety (RQS)
EMD Serono, United States
The US Orphan Drug Act and the European regulatory framework have accelerated orphan medicine development, boosting investments in rare disease treatments. This session will gather key stakeholders to discuss successes a and challenges
Learning Objective : Explore the impact of regulatory policies on the rare disease ecosystem; Discuss the challenges and opportunities associated with orphan drug regulations; Examine the role of regulatory frameworks in fostering innovation and access to therapies for rare diseases; Highlight the importance of collaboration between regulatory agencies, industry stakeholders, and patient advocacy groups.
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