Simplifying Global Compliance
Real World Evidence and the NEST Program: An FDA Perspective - Webinar Recording/Transcript
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Real World Evidence and the NEST Program: An FDA Perspective — Evaluating Benefit & Risk: What Devicemakers Need to Know
The FDA is working with stakeholders across the medical device community to simplify the evaluation of new medical devices via Real World Evidence (RWE). A key component of that effort is the National Evaluation System for Health Technology, or NEST … and it could benefit you.
One of the agency’s RWE leaders gives you a view into FDA’s thinking and activities related to the use of RWE and the exciting potential for NEST.
Owen Faris, Ph.D. is Director of the Clinical Trials Program at CDRH, FDA. Over the course of a fast-paced 90 minutes, he’ll bring you up to speed on how FDA views the current and potential uses of RWE for medical devices and what NEST may be able to do for you:
- Real World Evidence (RWE): Why the FDA is promoting it to evaluate medical devices
- How to support the NEST effort
- Proof of concept as it applies to using RWE for device evaluation
- Best practices and success stories
- Your specific medical devices: How RWE and NEST can specifically apply to their development
- And much more!
NEST is seen as a real opportunity to find “better, faster, cheaper” approaches to evidence-based generation for device evaluation … and get your new products to market and to patients in less time.
Devicemakers will benefit from this presentation in general. Job titles include but are not limited to:
- Regulatory/compliance
- Quality assurance
- Manufacturing/GMP/cGMP
- Supply chain executives
- Auditors
- Legal counsel
Owen Faris, Ph.D. is Director of the Clinical Trials Program in CDRH, FDA and has been a key leader in developing FDA’s approach to using RWE to inform regulatory decisions. Dr. Faris works closely with the NEST Coordinating Center so that FDA can partner with their efforts to build an RWE infrastructure that can help medical device developers, regulators, payers, clinicians and most importantly patients.