Shefali Rouen, PhD, is the Global Regulatory Lead for Biosimilars at Amgen, where they provide scientific and regulatory guidance to facilitate product market entry. Previously, Shefali held positions as Principal Scientist at Cardinal Health, Senior Medical Writer at PRA International, and Senior Scientist at Xenometrics, contributing to regulatory compliance and toxicology study design. They earned a PhD in Pharmacology and Toxicology and a Bachelor of Science in Genetics, both from the University of Kansas.
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