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Opening Remarks and Session 6: A 10 year Retrospective on RWE since the 21st Century Cures Act
Session Chair(s)
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
Speaker(s)
Simon Dagenais, PhD, MSc
Asset lead, Medical evidence development, Pfizer Inc, United States
Speaker
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