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Bethesda North Marriott Hotel and Conference Center

2026 年 10 月 19 日 7:00 上午 - 2026 年 10 月 20 日 5:00 下午

5701 Marinelli Road, North Bethesda, MD 20852

Real-World Evidence Conference

Translating Insights into Real-World Value

Opening Remarks and Session 6: 21st Century Cures Act – 10 Year Retrospective

Session Chair(s)

Simon  Dagenais, PhD, MSc

Simon Dagenais, PhD, MSc

Asset lead, Medical evidence development, Pfizer Inc, United States

Since the enactment of the 21st Century Cures Act in 2016, Real-World Evidence (RWE) has continued to evolve as an important component of healthcare decision-making, regulatory review, and biopharmaceutical development. This session will examine key milestones, policy developments, and methodological advances that have shaped the RWE landscape over the past decade. Using a timeline-based approach, speakers will explore how major events from 2016 to 2026 influenced the generation, evaluation, and use of RWE. The discussion will highlight contributions from biopharmaceutical companies, regulatory agencies, academic researchers, and industry partners involved in the development and application of real-world data (RWD) and RWE. This session is intended to provide attendees with an overview of key events related to RWE that have occurred in the past 10 years (2016-2026) since the 21st Century Cures Act was enacted

Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify key milestones that have shaped the evolution of RWE from 2016 to 2026
  • Describe how regulatory, scientific, and industry developments have influenced the use of RWE
  • Discuss the roles of key stakeholders in advancing the generation and application of RWE

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