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Navigating the New US and EU Rare Disease Regulatory Framework and Global Harmonization Efforts
Session Chair(s)
Imran Shah, PHD
SVP & Head, Global Regulatory, R&D Quality and Safety (RQS)
EMD Serono, United States
This session will assess the evolving global rare disease regulatory landscape and examine global harmonization efforts. Panelists will include leaders from FDA, EMA, NORD, Global Genes and they will discuss how get medicines to patients faster.
Learning Objective : Explore the evolving US and EU regulatory policy landscape; Examine how to advance global harmonization efforts for rare disease drug development; Discuss the opportunities and challenges on how to get rare disease medicines to patients faster.
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