Real-World Evidence Conference

Regulators, sponsors, and their collaborators continue to explore, share, and publish best practices and guidance documents to support RWE implementation in regulatory settings. They also seek practical alignment between regulatory guidance provisions and regulatory decisions involving RWE, particularly when RWE serves as primary evidence in regulatory submissions. High-quality open-source analytical tools and resources have quickly become available online for end-users seeking to (1) quickly gain actionable and meaningful regulatory intelligence using publicly available information, and (2) potentially determine the most effective RWE implementation strategies in regulatory submissions. Therefore, this session will present: • Publicly available tools and resources intended to support trust and transparency around regulatory decision-making regarding RWE; • Best practices and strategies around how to navigate publicly available tools and resources to extract meaningful and actionable regulatory insights focused on RWE; and • Methods to assess practical alignment between regulatory guidance provisions and regulatory decisions involving RWE using publicly available information.