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  4. Developing Real-World Data and Evidence to Support Regulatory Decision-Making - 10/03/2019 - 10/03/2019
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Workshop

Event Title
Developing Real-World Data and Evidence to Support Regulatory Decision-Making
October 03, 2019

Scheduled

Date:
October 03, 2019
Time:
09:00 AM - 05:00 PM EDT
Location:
Event Location
National Press Club
13th Floor - Ballroom

529 14th Street NW
Washington, DC 20045
United States


Registration:
https://healthpolicy.duke.edu/events/developing-real-world-data-and-evidence-support-regulatory-decision-making

Summary

In response to requirements under the 21st Century Cures Act and the sixth Prescription Drug User Fee Act (PDUFA VI), the FDA is exploring the use of Real-World Data (RWD) and resultant Real-World Evidence (RWE) in regulatory decision-making. Through extensive engagement with the stakeholder community, the FDA published a framework for the Agency’s RWE Program in December 2018. The framework outlines key considerations for evaluating the potential use of RWD and RWE for regulatory decisions related to the effectiveness for marketed products and is guided by a three-part approach:

  • Is the RWD fit for use? 
  • Does the trial or study design used to generate RWE provide adequate scientific evidence to answer or help answer the regulatory question of interest?
  • Did the conduct of the study meet FDA regulatory requirements?

This conference on Developing Real-World Data and Evidence to Support Regulatory Decision-Making is funded by FDA through a cooperative agreement with the Duke-Margolis Center for Health Policy and will bring together leading experts to examine these questions, other topics addressed in the framework, as well as emerging topics in the development of real-world data and evidence.

Registration

Please register at this website: Developing Real-World Data and Evidence to Support Regulatory Decision-Making

Contact

For more information, please contact the Duke-Margolis Center for Health Policy at margolisevents@duke.edu.