The signing of the Cures Act in 2016 marked a major milestone in signaling regulatory acceptance of real-world evidence (RWE). As recently as November 2021, the FDA issued additional guidance on the adoption of RWE further strengthening their support. As a result, the BioPharma industry has invested heavily in RWE programs and early adopters have seen promise in areas such as label expansion, safety studies, and clinical trial design. However, most organizations still wrestle with challenges like:
- How do we integrate large volumes of real-world data, including unstructured and semi-structured, and make it available to the teams that need it the most?
- How do we ensure reproducibility in RWE studies?
- How do we scale analytics across teams in an open and secure way?
Join this webinar to hear from regulatory affairs professionals, pharmaceutical company executives and leaders in data and AI as they discuss the challenges and opportunities for RWE across the drug lifecycle and lessons learned building successful RWE analytics programs.
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