Gain a comprehensive understanding of the latest advancements and regulatory updates in RWE from leading experts in the field
Engage with industry leaders, regulatory authorities, and peers to discuss innovative strategies and practical applications in RWE
Explore diverse use cases and methodological insights across early development, late-phase, and post-marketing scenarios to enhance your knowledge and practice
Discover cutting-edge technologies and operational strategies that are shaping the future of RWE generation
Examine the intersection of AI and RWE, and discuss the implications for policy and regulatory frameworks
October 9 – 10:00AM – 2:00PM ET | Virtual *Short Courses require an additional registration fee. You do not need to be registered for the conference to attend* The course will discuss the theoretical aspects of estimands as outlined in the ICH E9(R1) addendum, supplemented by hands-on examples to illustrate their use in real-world data contexts. Participants will learn about the five key attributes of estimands: target population, treatment condition, variable or endpoint, population-level summary, and strategies for handling intercurrent events, and understand why they are each crucial for effective study design. Participants will explore the challenges of defining and utilizing estimands, such as choosing analysis methods that most appropriately align with the defined estimand and avoiding misinterpretation.
October 16 – 9:55 – 10:25AM PST This presentation will highlight two case studies: (1) a GLP-1 comparative effectiveness study that produced results over a year before a major trial, later validated by trial findings, and (2) a device manufacturer that replicated registry outcomes with a significantly larger, more contemporary patient cohort. These examples showcase how real-world data can deliver timely, scalable, and clinically meaningful insights.