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Implementation of the FDASIA Patient Provisions


Continuing Education credits are not available for archived webinars

This archive will be available for purchase through February 28, 2015
Broadcast time: 1 hour 30 minutes

FDA has a long history of including the patient perspective through the FDA Patient Representative Program, where patients have been mainly included on Advisory Committees. The Food and Drug Administration Safety and Innovation Act (FDASIA) included multiple provisions to increase the inclusion of the patient perspective in FDA's decision-making.  This webinar will provide an overview of these new programs, and get an update on their implementation. Both Section 1137 of FDASIA and the Patient Focused Drug Development commitment in PDUFA V have moved to include the patient perspective earlier in regulatory discussions with industry. The session will provide a brief historical introduction, followed by a high-level overview of these new patient provisions. The FDA staff responsible for implementing these provisions will provide a detailed update on their progress and share their vision for the evolving role of patient advocacy in regulatory decision-making. A patient advocate will provide their views on FDA's progress in implementing these provisions, as well as the role that the patient advocacy community can play as partners in these initiatives.

Featured topics

  • Patient Representatives
  • Patient Focused Drug Development

Who should attend?

  • Industry patient engagement professionals
  • Patient advocates
  • Regulators interested in enhancing patient input

Learning objectives

At the conclusion of this webinar, participants should be able to:

  • Discuss the FDASIA enhancements to FDA’s patient advocacy programs 
  • Describe FDA’s progress and vision in implementing the various patient provisions
  • Identify opportunities for external stakeholders to engage with FDA’s patient advocacy programs

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