Register: Webinar Registration – Zoom

Description: Real-world evidence is no longer “emerging”… it’s actively shaping regulatory decisions today. In this 60-minute, conversational webinar co-hosted by 3Aware and MED Institute, we’ll unpack what’s changed in the last few years (including the FDA’s FY2020–2025 RWE examples) and what it takes to build a repeatable, fit-for-purpose evidence approach—rather than one-off “compliance fire drills.”

Can’t attend live? Register anyway—all registrants will receive the event recording.

Expert Presenters:

• Scott Williams, MS, RAC – Vice President, Regulatory and Clinical Services, MED Institute
• Samantha Stevenson, MPH – Director, Clinical Services, MED Institute
• Amelia Hufford, PhD – Senior Vice President, Clinical and Regulatory Science, 3Aware

What you’ll learn:

• Where RWE is showing up most often in regulatory pathways today: 510(k), De Novo, PMA, labeling changes, lifecycle evidence
• Why medical records/EHR-based evidence is increasingly important—and how newer data sources are expanding what’s possible
• A practical playbook for sustainable compliance: start with the question → define fit-for-purpose data needs → pressure-test feasibility early → use defensible methods and follow GCP → make it auditable and repeatable
• Common misconceptions and pitfalls, and how to avoid them Submit your questions! We’ll close the session with a live Q&A and provide pragmatic takeaways for building defensible evidence programs. Whether you’re currently facing a specific evidence question or looking to scale RWE capabilities across an entire portfolio, you’ll leave this session with a clear understanding of “what to do next” to advance your evidence strategy.