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Navigating the New US and EU Rare Disease Regulatory Framework and Global Harmonization Efforts
Session Chair(s)
Elizabeth Lange, MPH, MS
VP & Head of Global Regulatory Science, Policy and Intelligence
XX, 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 : Describe 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.
Speaker(s)
Representative Invited
FDA, United States
Panelist
Representative Invited
European Medicines Agency, Netherlands
Panelist
Representative Invited
European Medicines Agency, Netherlands
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