IQVIA’s experts lead a conversation on embracing FDA’s guidance on the use of real world data (RWD).
The entire healthcare ecosystem is embracing a mission of innovation, including regulatory agencies like the FDA. Guidance documents on the use of RWD released over the past year are shaping the future of evidence generation and Regulatory Science. In addition to new methods and approaches, quality and curation of RWD collected from a variety of sources are key themes in FDA’s guidance and can impact utilization. In this webinar, Mui Van Zandt, BS and Raina Olexa, MS discuss how your organization can navigate data quality, curation, and management challenges for better research.
Key Topics Include:
- Discover the big picture of FDA’s 2021 real world evidence guidance
- Understand common data quality challenges, how you can overcome these issues, and how you can apply data quality concepts in your organization
- Learn how data quality measures can help provide transparency for better research
- Discover a systematic approach to monitor data quality that has been implemented at IQVIA across 100’s of sources of global data
- Hear use cases for RWD application and utilization
Click to watch the webinar recording. To view the presentation full screen simply click the square icon located in the bottom-right corner of the video-viewer.
Presenters
Senior Principal Scientist
Regulatory Science & Strategy
IQVIA
Raina Olexa has over 20 years of medical research and pharmaceutical experience, working across all stages of the product lifecycle. She conducted pre-clinical neurobiology research to assess recovery of function in animal models of spinal cord injury before moving into the field of vaccine and biologics manufacturing.
VP and GM
Real World Data and Technology
IQVIA
Mui Van Zandt is experienced in systems/application development, focusing on business analysis and project management. Her duties have spanned the spectrum of the system life cycle – from initial concept definition, analysis, design, testing, and implementation to operations and maintenance.
Production Partner
IQVIA
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise.
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