Danelle R. Miller is Vice President, Global Regulatory Policy and Intelligence for Roche Diagnostics. In that role, she is responsible for guiding Roche Diagnostics’ global regulatory policy efforts. Ms. Miller joined Roche Diagnostics in 2005, and served as Regulatory Counsel for Roche Diagnostics’ Indianapolis-based affiliates, and later as Global Regulatory Counsel, where she counseled Roche Diagnostics worldwide on quality and regulatory issues. Prior to joining Roche Diagnostics, she worked for the law firm of Baker & Daniels, where she was responsible for representing food, drug and medical device companies on regulatory and related issues involving the Food and Drug Administration and other federal and state agencies. Ms. Miller also has served as Regulatory Counsel for a major pharmaceutical firm. Ms. Miller holds a B.S. from the University of Tulsa, M.A. from Ball State University, and a J.D. with high honors from the University of North Carolina School of Law.
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For #TestCaseTuesday, check out our case study for a project that evaluated data relevance and reliability to assess if real-world data would be “fit for purpose” for regulatory submission supporting a potential study for label expansion. Download: hubs.ly/Q018VCNy0 pic.twitter.com/T9Gu4uM8uS 4 months ago