Error loading player: No playable sources found

AM23-TU-09-O

AM23-TU-09-O: How Does the FDA Use Real World Data and Real World Evidence? (Enduring)

Credits
1 General Continuing Education (GEN) | 1 Florida Lab Personnel (FLP) | 1 California Nurse (CN) | 1 California Lab Personnel (CLP) | 1 Physician (PHY)
$3000
Standard Price
Members save $5

The FDA uses Real Word Data (RWD) to evaluate biologics. RWD is data relating to patient health status/health care delivery. It may be found in Electronic Health Records (EHRs), claims, registries, etc. RWD-informed benefit-risk assessments (B-RA) have been used for evaluating interventions for SARS-CoV-2, including COVID vaccines and convalescent plasma (CCP). Real World Evidence (RWE) is clinical evidence about the usage and potential benefits/risks of a product and is derived from the analysis of RWD. CBER Biologics Effectiveness and Safety Initiative (BEST) explores RWD to identify and assess exposures to blood, biotherapies, and vaccines and subsequent potential adverse events. We describe types of RWD and how the FDA assesses its relevance/use in evaluating safety and effectiveness. We will show how CBER is using RWD/RWE to support B-RA and consider future directions to enhance the authorization, approval, and safety of CBER-regulated products.

Learning Objectives

  • Describe Real World Data (RWD) and its use in FDA post-market safety surveillance. Recognize the important new developments in data integration relevant to RWD and electronic health record (EHR) use for regulatory purposes.
  • Identify the tools and resources FDA uses to monitor current exposures to biologics, to mine outcomes, and explain how they can be applied to improve public health.
  • Discuss the FDA Benefit-Risk framework for new drug and biological products and how RWD can inform parameters for these risk assessments.

Moderator

Speaker Image for Barbee Whitaker
Lead General Health Scientist, FDA/CBER

Speakers

Speaker Image for Hussein Ezzeldin
Senior Staff Fellow, US FDA
Speaker Image for Osman Yogurtcu
Senior Staff Fellow, FDA/CBER

Tracks

Related Products

Thumbnail for AM24-MN-43-O: Trans, Non-binary, and Gender-Diverse Peoples: How You Can Make a Difference for Donors, Patients, and Communities (Enduring)
AM24-MN-43-O: Trans, Non-binary, and Gender-Diverse Peoples: How You Can Make a Difference for Donors, Patients, and Communities (Enduring)
Many blood operators around the world are implementing individualized donor assessments that welcome more trans, non-binary, and gender-diverse people to donate…
Thumbnail for AM24-MN-36-O: From Courts to Congress: Navigating the Healthcare Policy Landscape in 2024 (Enduring)
AM24-MN-36-O: From Courts to Congress: Navigating the Healthcare Policy Landscape in 2024 (Enduring)
In today’s rapidly evolving healthcare environment, understanding the latest policy developments is crucial for strategic planning and operational success. This session will explore the significant implications of the recent Supreme Court decision – Loper Bright Enterprises v…
Thumbnail for AM24-ST-29-O: Case Studies: Cyber Threats in Healthcare (Enduring)
AM24-ST-29-O: Case Studies: Cyber Threats in Healthcare (Enduring)
Join us for an essential panel discussion on cybersecurity in healthcare, where real-world insights and expert analysis come together to enhance your organization's defenses. This session features three distinguished speakers from hospitals and blood centers that have faced cybersecurity attacks…
Thumbnail for AM23-MN-34-O: Transfusion Transmissible Infections Monitoring System (TTIMS): Tools to Assess the Safety of the Blood Supply Over Time (Enduring)
AM23-MN-34-O: Transfusion Transmissible Infections Monitoring System (TTIMS): Tools to Assess the Safety of the Blood Supply Over Time (Enduring)
This session will review the Transfusion Transmissible Infections Monitoring System (TTIMS) program scope and activities…