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

CDER SBIA Webinar: Framework for FDA’s Real-World Evidence Program 

Friday March 15, 2019

11:30 AM – 12:30 PM EDT

*  Register Here  *

This event is free

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.

Director, Office of Medical Policy

Center for Drug Evaluation and Research, FDA

FDA Resources

1. FDA: Real World Evidence
2. Framework for FDA’s Real World Evidence Program

Meeting Materials

• Slides will be available for download on the day of the event.

Continuing Education

• 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.

Webcast Information

• Upon registration, you will receive an acknowledgement email which will provide the webcast link. This link will be activated on the day of the event.

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