Statistical and Quantitative Methods for Pharmaceutical Regulatory Science

Harvard HSPH

The goal of this course is to enable scientists and public health professionals who already have an introductory background in biostatistics and clinical trials to acquire the competencies in quantitative skills and systems thinking required to understand and participate in drug development and regulatory review processes. The course illustrates how statistical and quantitative methods are used to transform information into evidence demonstrating the safety, efficacy and effectiveness of…