Menu Back to 012A-Real-World-Evidence-The-Evolving-Landscape-of-Regulators-Data-and-Integrated-Use

Overview

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.
This short course will provide an overview of how real-world evidence is being used today for evidence generation in major markets. The primary focus is evidence generation for regulatory use, with a particular focus on comparative effectiveness, but the approaches described here are useful for health technology assessments for payers. Following the major points identified by the FDA in the Frameworks document released in December, 2019, we will explain how the fitness of evidence from real-world data are assessed for any use case, key elements of design and analysis, and the current status of FDA guidance on when real-world studies will be sufficient to meet regulatory evidence requirements. Although much of the focus will be on the FDA, the course will also include an update of recent activities by the EMA regarding use of real-world (big) data.

Need approval in order to attend?

Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.



Enhance your experience and register for two or more short courses at the same time and receive $50 in savings.
Purchase must happen at same time. Discount will be reflected on the last page of the cart.


Upon completion of registration, participants will gain access to the following:

  • Live Event Access
  • Presentation Slides
  • Access to recorded sessions, on demand for 4 months post event


Download Registration Form

Registration Questions?

Send Email
1.888.257.6457


Return to

DIA 2021


Who should attend?

This short course is designed for members of the clinical research and regulatory audiences.

Learning objectives

At the conclusion of this short course, participants should be able to:
  • Describe key epidemiological design principles central to interpreting the quality and validity of real-world evidence (RWE) studies
  • Apply these learnings by evaluating and discussing case presentations focused on CV safety assessments.
  • Recognize when RWE based approaches are of sufficient quality to enable decision making.