Training: Pfizer

● Interface Between Regulation and Statistics in Drug Development ● Birol Emir, PhD, FASA ● RWE Statistics Group Head, Global Biometrics and Data Management, Statistical Research and Data Science Center ● Pfizer Research & Development

Duration: 3 Hours | Quota: 40 Participants | October 15, 2024, 14:30-17:30

Description:

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.

The last hour of the training will be devoted to Leadership in Statistics. After a brief presentation, there will be a panel discussion and a question/answer session with the audience.

Background:

With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible. This course is aimed to fill that gap for the statisticians with limited experiences in this area, orthose experienced statisticians who wish to refresh their knowledge of current topics or keep up-to-date on best practices and regulatory developments.

Course Outline:

Part 1 introduces basic statistical and regulatory issues with special reference to the role of regulations and guidance documents, and the evolving role of the statistician vis-à-vis the changing regulatory and healthcare landscapes. In Part 2, we will discuss major statistical issues that commonly arise in the course of drug development and regulatory interactions, outlining measures that should be taken to ensure the validity of inferential results that are intended to be the basis for regulatory decision. The discussion will be illustrated with respect to regulatory guidance documents and best practices. Part 3 highlights the role of the statistician in the course of drug development, with special emphasis on the skills required to ensure effective interactions with regulatory and other external bodies. Part 4 addresses trending topics in drug development, with emphasis on the current regulatory thinking and the associated challenges and opportunities

Learning Outcomes:

At the end of the course, we believe that the course participants will have a good understanding of  the statistical and regulatory issues that commonly arise in the course of drug development. Notably, prospective attendees of this course will get a thorough appreciation 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 that are essential in their interactions with internal stakeholders and external partners, including DMCs and regulatory bodies.