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ViewAttendees 22

Medical Devices

Domain: Regulatory Frameworks & Strategy

Knowledge Area: Data Management & Analysis

Real World Evidence...What Could Possibly go Wrong? A Clinician's Perspective

Friday, May 12, 2023
12:00 – 13:00 CEST
Location: Pearl 2

Supported By
Description: The term real-world evidence (RWE) has become a catchall term covering any clinical data derived out with traditional clinical trials. The use of real-world evidence to support regulatory decision-making offers a number of distinct advantages in comparison to traditional clinical trials. However, this real-world evidence is not a panacea and like any clinical data source is subject to bias, missing data and unreliable information from systems not designed to produce clinical evidence.

This session will discuss the opportunities and development of gathering real-world clinical evidence in order to support regulatory decision-making. The need to understand the limitations of RWE as part of an overall regulatory strategy will be highlighted. Finally, the session will discuss the expectations of clinical experts reviewing this RWE submitted to a notified body.

Learning Objectives:

  • Describe the potential limitations of real world evidence.
  • Develop a real world evidence strategy to support regulatory decision making.
  • Understand the expectations of clinical reviewers looking at real world evidence submitted to Notified Bodies.