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FDA Guidance 2021 - How to Implement a Real-World Data Study for Regulatory Decision-Making Following the New FDA Draft Guidance



VenueLIVE WEBINAR, Canada Canada

KeywordsReal-World Data; FDA Guidance; Regulatory Affairs


Topics/Call fo Papers

Who Should Attend?
Clinical Operations
Clinical Development
Medical Directors/Chief Medical Officers
Medical Affairs
What You Will Learn
Join 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Understand the new FDA draft guidance on real-world data in regulatory decision-making and implications of the guidance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Learn how to best apply the draft guidance to run studies on a real-world data sample with the intent of submitting to the FDA
Recognize what a study look would like that meets the FDA guidance

Last modified: 2021-11-20 03:26:54