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Webinar: Framework for FDA’s Real-World Evidence Program – Mar 15, 2019

Webinar: Framework for FDA’s Real-World Evidence Program – Mar 15, 2019

SBIA Webinar 2016
Date and Time
March 15, 2019
11:30am - 12:30pm (EDT)

About this Webinar

As part of the 21st Century Cures Act, the FDA released a framework for our Real-World Evidence (RWE) program.  The goal for this webinar is to inform the public of FDA’s effort to understand the utility of real-world data (RWD) to generate evidence for regulatory decisions.

Learning Objectives

At the end of this webinar, participants will be able to:
1.Describe the main elements of FDA’s real-world evidence (RWE) Program.
2.List FDA considerations for evaluating the use of real-world data to generate RWE for regulatory decisions.
3.Explain program items the Agency plans to address in the RWE Program.
4.Describe at least one demonstration project that will help inform the use of RWD and RWE.

Who Should Attend

Stakeholders working on RWD and RWE to include:

  • Regulatory affairs professionals
  • Academia
  • Clinical research organizations
  • RWD Curators

FDA Speaker

Jacqueline Corrigan-Curay, J.D., M.D.
Office of Medical Policy
Center for Drug Evaluation and Research

Continuing Education

  • This course is eligible for 1 CE credit for physicians, nurses, pharmacists, or pharmacy technicians. Please refer to the course CE announcement for complete information.
  • This one-hour webinar is RAPS eligible for up to 1.0 credit towards a participant’s RAC recertification upon full completion.
  • This event is SQA approved for 0.25 non-GCP or non-GLP units per 1 hour towards RQAP re-registration
  • ACRP provides continuing medical education for the completion of this educational activity. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
  • Attendance certificates are only available during the two weeks after the event. Attendance is required.

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