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Session Chair(s)
Steve Wilson, PHD
Senior Staff Fellow, OB, OTS, CDER
FDA, United States
Learning Objective : Discuss key developments associated with the regulatory science initiatives and how they relate to statistics; Recognize the impact of the new guidance, collaborative efforts and the role of statistics in the quantitative thinking needed to transform how medical products are developed, evaluated and manufactured; Identify opportunities for FDA, industry and academia to collaborate in developing methodologies for the quantitative decision-making needed for medical product development.
Speaker(s)
FDA Perspective
Robert T. O'Neill, PHD
FDA, United States
Senior Statistical Advisor, Office of Translational Sciences, CDER
Advisory Committee Perspective
Ralph B. D'Agostino, PHD, MA
Boston University, United States
Chair, Mathematics and Statistics Department
Academic Perspective
Marcia Testa, MPH
Harvard School of Public Health, United States
Senior Lecturer
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