Short Courses: April 12-13
Forum: April 14-16

The DIA/FDA Biostatistics Industry and Regulator Forum is a unique forum addressing the statistical issues associated with the development and review of therapeutic drugs, biologics, devices, combination, and other medical products. As an open forum to discuss timely topics of mutual theoretical and practical interest to statisticians and clinical trialists, this meeting focuses on the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials data and measuring the progress with the implementation of innovative solutions.

An important purpose of the forum is to advance the dialogue between industry, regulatory agencies, and academia around policy, regulation, development, and review of medical products in the context of today’s scientific and regulatory environments. The program is developed collaboratively by FDA, industry, and academic experts who team up to ensure that each session brings all stakeholder perspectives to the discussion.

Attend the DIA/FDA 2021 Biostatistics Industry and Regulator Forum and join leading edge discussions: statistical analyses in COVID-19 interrupted trials and therapeutic/vaccine trials, RWE and its use in regulatory decision making pre-marketing, approaches to the incorporation of external controls – applicability and methods, the FDA RCT DUPLICATE project, enhancing diversity in clinical trial populations, and so much more!