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Expedited Regulatory Pathways: Speed vs. Haste
Session Chair(s)
Ling Su, PHD
Research Fellow
Yeehong Business School, China
Expedited regulatory pathways offer the potential to accelerate the development and approval of promising new drugs treating serious, lifethreatening diseases and fulfilling unmet medical need. However, it is important for sponsor to derive and implement practical development strategies upon a thorough understanding of the regulatory requirement and guidance in order to realize the potential of expedited pathways and avoid the pitfalls. In this session, speakers and panelists will discuss the experience around conditional approval and singlearm trials.