We could all us use a dose of sunshine right now!  Come enjoy a relaxed evening of networking, delicious bites, & painting-plus a chance to discover what SDRAN has in store for this season, from educational programs & RAC study groups to mentoring opportunities and more.   Admission includes appetizers, libations, & an instructor lead paint class. Registration required. Must register by Feb 22nd

Program Topic: The regulatory landscape for medical products is rapidly evolving as regulators and industry alike recognize the value of Real-World Evidence (RWE) and Real-World Data (RWD) in enhancing regulatory decision-making. As healthcare data increasingly reflects real clinical practice rather than controlled study environments, the FDA is recalibrating how evidence is generated, evaluated, and applied across medical devices, drugs, and biologics. Recent FDA policy changes and updated guidance documents mark a significant evolution in the Agency’s approach to RWE. FDA claims to have removed key barriers that previously limited the use of real-world evidence, most notably by enabling broader consideration of de-identified and aggregated data sources. FDA is also emphasizing a fit-for-purpose framework focused on data quality, relevance, and methodological rigor rather than data origin alone. New and updated guidances spanning medical devices as well as drugs and biologics provide clearer expectations for how RWE may support regulatory submissions and underscore the importance of early engagement with FDA to align on evidence strategies. In this presentation, Dr. Steven Weber will examine how the evolving FDA landscape is shaping the use of RWE across product types, highlight practical considerations for sponsors, and explore how real-world data can be strategically leveraged to support premarket submissions while maintaining robust standards for safety and effectiveness. Speaker Biography: Stephen Weber, MD is a former FDA medical reviewer with extensive experience evaluating the safety and effectiveness of medical products across the regulatory lifecycle. During his tenure at the Agency, Dr. Weber played a key role in the scientific review of submissions supporting market authorization, post-market safety oversight, and regulatory policy development. He brings deep expertise in clinical evidence evaluation, benefit–risk assessment, and regulatory strategy, helping sponsors navigate complex FDA interactions with clarity and efficiency. Dr. Weber is recognized for his ability to translate regulatory expectations into actionable development plans that support successful product approvals.