Module 12 Presentations

Key Definitions 3. Real World Evidence o The U.S. Food and

Drug Administration (FDA) defines RWE as “the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data"

Source: https://www.fda.gov/science-research/science and-research-special-topics/real-world-evidence

The Organisation for Professionals in Regulatory Affairs