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Streamlined Trials Embedded in Pragmatic Settings
Session Chair(s)
Kevin Bugin, PHD, MS, RAC
Head of Global Regulatory Policy and Intelligence
Amgen, United States
Randomized pragmatic clinical trials (rPCTs) and streamlined trials embedded in practice (STEPs) can generate regulatory-grade evidence. This workshop will address operational hurdles, regulator expectations, and global convergence opportunities.
Learning Objective : Define regulatory expectations for pragmatic RCTs in alignment with ICH E6(R3); Identify operational strategies to ensure data quality and integrity; Examine global initiatives (FDA, EMA, ICH) for convergence opportunities; Develop practical frameworks for regulator-sponsor alignment.
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