Statistical and Quantitative Methods for Pharmaceutical Regulatory Science

BST 217 Subject & Catalog Number

Description

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 drugs and devices over the course the product's life cycle from a regulatory perspective. Content is delivered using a blended-learning approach involving lectures, web-based media and selected case study examples derived from actual FDA decision-making and regulatory assessments to highlight and describe each phase of the regulatory drug approval process. Case studies will illustrate regulatory science in action and practice and will include content publicly available from the FDA's website that can be used in conjunction with FDA science-based guidances and decision precedents.