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Oct 12, 2023 10:00 AM - Oct 12, 2023 2:00 PM

Short Course: How Good is Good Enough? Fit-for-Purpose Considerations for RWD/RWE for Regulatory Purposes

This Pre-Conference Short Course is held in conjunction with the Real-World Evidence Conference


*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*

This Short Course will be offered virtually – Join from anywhere!

Back by popular demand, this short course will describe the myriad of factors that scientists and other stakeholders should consider when determining whether – and how – to use real-world evidence (RWE) and select proper real world databases (RWD) to support regulatory submissions to the United States Food and Drug Administration (US FDA). This course will interpret and apply recent draft guidance documents related to RWE issued by the US FDA and use case studies – both successful and unsuccessful – to highlight key learnings. We will also review common biases and proper exposure definitions when conducting RWE studies.

Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

This Short Course pairs nicely with Short Course #2: Measuring the Quality of Real-World Data (RWD). If you register for both Short Courses and the Real-World Evidence Conference, you will automatically receive $150 off in your cart!

Learning objectives

Upon completing this course, attendees will be able to:
  • Identify key components of RWD quality in the context on regulatory submission
  • Discuss basic study design considerations in RWE for regulatory submissions
  • Recognize sources of bias and considerations for proper exposure definitions in RWE

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