Real-World Evidence in Medical Product 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.
FDA regulatory experts Kristin Zielinski Duggan, Lynn Mehler and Sally Gu dig into the FDA’s guidance around RWE as support for regulatory decision-making and detail key examples of how this evidence has been used. They discuss the limitations of these approaches and the steps you can take to ensure the validity and usefulness of your data.
Key Webinar Takeaways:
- FDA Guidance and Documentation
- Understanding the FDA’s guidance document on the use of RWE to support regulatory decision-making for medical devices and pharmaceuticals
- Analyzing the FDA’s framework for the RWE program
- Exploring illustrative examples of RWE used in medical device and pharmaceutical 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 Presenters
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. Duggan 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.
Lynn Mehler is a partner and co-head of Hogan Lovell’s Life Sciences & Health Care industry sector and head of its Pharmaceuticals and Biotechnology practice. She is a 12-year veteran of the FDA's Office of the Chief Counsel. She has worked extensively on the approval processes for new drugs and biologics and on pharmaceutical safety issues, including development and modification of risk evaluation and mitigation strategies (REMS).
Sally Gu is an associate at Hogan Lovells. She advises pharmaceutical and biotechnology companies on FDA preapproval product development issues, regulatory strategy and postmarketing compliance. She has worked on digital transformation initiatives and helped clients with novel products navigate evolving regulatory frameworks for digital health technologies, real-world evidence and patient-focused drug development.
Who Will Benefit
- Medical device companies
- Pharmaceutical companies
- Groups considering reliance on RWD/RWE
- Management teams
- Research and development staff
- Regulatory affairs professionals
- Quality professionals
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Oct. 19, 2022