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Director, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
Samantha Roberts is currently a Group Director in Roche/Genentech's US Regulatory Policy office where she focuses on the implementation of regulatory policy priorities to modernize and improve the efficiency of drug development and review. Before joining Roche/GNE in 2016, she worked...
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Director, Science and Regulatory Policy, Astellas
Dr. Raymond currently serves as Director, Science and Regulatory Policy at Astellas. Prior to joining Astellas, Dr. Raymond served as a Director, Science and Regulatory Advocacy at PhRMA. In this role he focused on regulatory policy and advocacy issues including combination products...
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Global Head Pharmacometrics, Pfizer Inc
Daniele Ouellet, PhD, is Vice-President and Global Head of Pharmacometrics at Pfizer, where her focus is to apply model informed drug development (MIDD) principles to the portfolio. In her current role, Daniele is responsible for a group of Pharmacometricians who provide MIDD input...
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Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER, FDA, United States
Dr. Madabushi has 10 years of regulatory review experience as Pharmacometrics Review and as Team Leader in the Office of Clinical Pharmacology. He was predominantly involved in the application of quantitative clinical pharmacology approaches for regulatory decision making and addressing...
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