Real-World Evidence in Medical Device Submissions: What Regulatory, Compliance & Quality Professionals Need to Know – Webinar Recording/Transcript
There’s been a shift in the acceptance of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making. What was once considered merely anecdotal is now deemed reliable. Between the FDA’s final 2017 guidance, the RWE Framework document from 2018 and the April 2021 report on RWE-based decisions, the agency is showing its increasing emphasis on real-world information.
The FDA’s Center for Devices and Radiological Health (CDRH) is moving with this trend, but it’s unclear whether FDA policies have actually evolved.
FDA regulatory expert Kristin Zielinski Duggan digs into the FDA’s guidance around RWE as support for regulatory decision-making and detail key examples of how this evidence has been used for medical device decisions. She discusses the limitations of these approaches and the steps you can take.
Key Webinar Takeaways:
- FDA Guidance and Documentation
- Understanding the FDA’s guidance document on the use of real-world evidence to support regulatory decision-making for medical devices
- Analyzing the FDA’s framework for the RWE program
- Exploring illustrative examples from the FDA’s April 2021 report on examples of RWE used in medical device regulatory decisions
- Practicalities of Relying on RWD/RWE
- The limitations of turning to RWD and RWE
- Steps to successfully use RWD and RWE
- Premarket and Postmarket Obligations
- Using RWD and RWE for premarket and postmarket obligations
The FDA is shifting its acceptance of real-world data and evidence. If you’re planning on relying on RWD and RWE, you’ll need to understand these changes. Stay ahead of the curve and determine the best path forward.
Meet Your Presenter
Kristin Zielinksi Duggan, partner at Hogan Lovells, has extensive experience with the entire FDA regulatory process and agency interactions, from devising regulatory strategy for innovative products to presubmission meetings. She previously served as vice president for strategic consulting at a scientific consulting firm in Washington, D.C., and has published and presented on various FDA regulatory issues. Zielinksi is also an adjunct professor at Georgetown University’s School of Nursing and Health Studies, where she teaches an experiential seminar on FDA regulation of medical products.
Over her career Zielinksi has gained experience assisting with preclinical and clinical programs and IDEs; preparing regulatory submissions, de novo petitions and premarket approvals; and appealing agency decisions. She has been involved with all the meetings of the Medical Devices Dispute Resolution Panel (MDDRP) to date and assists companies with compliance challenges, including 483 and warning letter responses, adverse events reporting, recalls, Department of Justice investigations and product liability litigation.
Who Will Benefit
- Medical device companies
- Groups considering reliance on RWD/RWE
- Management teams
- Research and development staff
- Regulatory affairs professionals
- Quality professionals
- Submissions and approvals staff
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May 10, 2022