The FDA Real-World Evidence (RWE) Framework was published in Dec. 2018, shedding some light on how Real-World Data (RWD) can be used to support regulatory decision making. This guidance was greatly welcomed in an environment that focuses on efficiency and innovative trial designs. Yet, three years out, there are not many examples of RWE in practice, especially of situations where RWE is the exclusive source of evidence supporting new drug indications. Recently, tacrolimus was approved for Lung transplantation based solely on RWE and we would like to share our experience with statisticians in the pharmaceutical community.

Three stakeholders – the sponsor, RWD vendor and FDA - will share their experiences of the submission and approval process. Topics to be covered include relevant project background & context, identification/selection of RWD, study design & key analysis methods, operational considerations related to study conduct & quality, submission content and labeling.

Who is this event intended for? Statisticians or other professionals with an interest in the use of real world data in the regulatory setting.

What is the benefit of attending? To hear first-hand experience of a successful RWE-based submission from different stakeholder perspectives.