CE_22C: Interface between Regulation and Statistics in Drug Development (Added Fee)

This course is aimed primarily at statisticians who are relatively new to the pharmaceutical industry and wish to broaden their knowledge and understanding of the interplay between statistics and regulatory science in drug development. The main focus of the course is raising awareness in the intersection of statistics and regulatory affairs, with special emphasis on salient features of traditional and emerging issues and methodologies in the design, conduct, analysis, and reporting of clinical trials or observational studies intended for regulatory purposes. While the course is aimed at statisticians with limited experiences in this area, it may also be of benefit to other more experienced statisticians who wish to refresh their knowledge of current topics or keep up-to-date on best practices and regulatory developments. The course consists of four sections, with each section dedicated to a specific topic in regulatory affairs and statistics. In each case, the topic will be discussed from both the statistical and regulatory perspectives. We will highlight current and emerging trends and suggest appropriate best practices. Notably, the course will also cover the recent progress in machine learning and Big Data analytics and the prevailing regulatory thinking on the integration of these new techniques in drug development. Issues of processing, analyzing and reporting multi-dimensional data will be highlighted, with special reference to the attendant concerns about data integrity, privacy and confidentiality. While most statisticians graduating from universities have solid theoretical and applied exposures, they typically lack knowledge of the rationale for the regulatory requirements that must be adhered to in drug development. So, prospective attendees of this course will get a thorough understanding of the current state of the statistical and regulatory sciences in the context of pharmaceutical research. In addition, attendees will be exposed to the behaviors and capabilities expected during DMC and other external interactions.