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FDAnews Announces Real-World Evidence in Medical Device Submissions Webinar Nov. 3, 2021

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WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (PRWEB)

Real-World Evidence in Medical Device Submissions

An FDAnews Webinar

Wednesday, Nov. 3, 2021, 1:30 p.m. – 3:00 p.m. EDT

https://wcg.swoogo.com/real-world-evidence-in-medical-device-submissions

The use of real-world data (RWD) and real-world evidence (RWE) is on the rise. There’s been a shift in how this type of evidence is accepted — both by medical device developers and the FDA. What was once considered merely anecdotal is now deemed reliable.

The FDA’s Center for Devices and Radiological Health (CDRH) is moving with this trend, and any organizations hoping to use real-world data or evidence in their pre-market and post-market obligations will benefit from a deeper understanding of these changes.

FDA regulatory expert Kristin Zielinski Duggan will 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 for medical device decisions. She will discuss the limitations of these approaches and the steps one can take.

This webinar will cover:

● FDA Guidance and Documentation

a. Understanding the FDA’s guidance document on the use of real-world evidence to support regulatory decision-making for medical devices

b. Analyzing the FDA’s framework for the RWE program

c. 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

a. The limitations of turning to RWD and RWE

b. Steps to successfully use RWD and RWE

● Pre-market and Post-market Obligations

a. Using RWD and RWE for pre-market and post-market obligations

The FDA is shifting its acceptance of real-world data and evidence. If one is planning on relying on RWD and RWE, one will need to understand these changes. Stay ahead of the curve and determine the best path forward.

Webinar Details:

Real-World Evidence in Medical Device Submissions

An FDAnews Webinar

Wednesday, Nov. 3, 2021, 1:30 p.m. – 3:00 p.m. EDT

https://wcg.swoogo.com/real-world-evidence-in-medical-device-submissions

Tuition:

$297 per site

Easy Ways to Register:

Online: https://wcg.swoogo.com/real-world-evidence-in-medical-device-submissions

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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