Reality Check - Ideas and Trends in Real World Evidence from a Regulatory Perspective
PHASTAR is delighted to announce our second webinar of 2020. Dr. LaRee Tracy, PHASTAR’s Director of Biostatistics will present her presentation on 'ideas and trends in real world evidence from a regulatory perspective’.
Interested? Click here to register.
Date: Wednesday 8th April, 1pm PST
What to expect from this webinar:
This webinar will discuss current concepts of real world data and real world evidence, summarize the US Food and Drug Administration’s framework on Real World Evidence mandated by the 21st Century Cures Act, and highlight recent regulatory approvals in which real world evidence was relied upon in the evaluation of product safety and effectiveness.
About the speaker:
Dr. LaRee Tracy, Director of Biostatistics
LaRee leads PHASTAR’s San Diego office, which serves as a strategic operational hub to support PHASTAR’s west coast customers and is a key component of the company’s current 5-year growth plan.
LaRee brings to PHASTAR more than 24 years’ experience in clinical research, industry regulation and clinical operations, including over 16 years working as an FDA CDER statistician. Her areas of expertise include biostatistics, experimental and observational study design, as well as significant experience with FDA processes and regulations.