Implications of new FDA draft guidance on real-world data explained in upcoming webinar hosted by Xtalks
In this free webinar, attendees will understand the new FDA draft guidance on real-world data in regulatory decision-making, including implications of the guidance, and determine what data should look like in order to meet FDA guidance. The featured speakers will also discuss how to best apply the draft guidance to run studies on a real-world data sample with the intent of submitting it to the FDA.
TORONTO, Dec. 1, 2021 /PRNewswire-PRWeb/ -- The FDA has issued two new draft guidance documents on the use and structure of real-world data in regulatory decision-making. While real-world data has been around for many years, the speakers on this webinar will recap the guidance and discuss what this means for the use of real-world data going forward. In particular, they will discuss the key requirements for real-world data to be suitable for regulatory decision-making and how those requirements differ from traditional uses of real-world data.
They will use real examples from their own proprietary dataset as exemplars of how real-world data can be collected in a manner that enables data studies that are fit for regulatory decision-making.
Register for this webinar to:
- Understand the new FDA draft guidance on real-world data in regulatory decision-making and implications of the guidance
- Determine what data should look like in order to meet FDA guidance
- Learn how to best apply the draft guidance to run studies on a real-world data sample with the intent of submitting it to the FDA
- Recognize what a study would look like that meets the FDA guidance
Join expert speakers from xCures, Mark Shapiro, Chief Operating Officer and Principal Investigator, XCELSIOR; Max Goldstein, Vice President of Research Partnerships; and Bryan Federowicz, Vice President of Clinical Operations, for the live webinar on Thursday, December 16, 2021, at noon EST (5 pm GMT/UK).
For more information, or to register for this event, visit How to Implement a Real-World Data Study for Regulatory Decision-Making Following the New FDA Draft Guidance.
ABOUT XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/
Media Contact
Sydney Perelmutter, Xtalks, +1 (416) 977-6555 x 352, [email protected]
SOURCE Xtalks
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