Webinar: Let's Get Real: How Will the FDA Framework for Real-World Evidence Impact You?

How is real-world evidence (RWE) really being used, and how will the Food and Drug Administration's (FDA) new framework for RWE affect decision-makers beyond the FDA? The National Pharmaceutical Council (NPC) hosted a webinar to showcase the potential implications of the FDA framework for patients, payers, manufacturers and other health care stakeholders.

This webinar provides:

  • An overview of how the FDA currently uses RWE, and what a future in which RWE is commonly used might look like;
  • A deeper dive into new research describing the current use and contribution of RWE, the implications for and needs of the patient and patient advocacy community, and how the patient community is preparing for broader use of RWE;
  • A payer’s perspective on the current use of RWE, how the payer community is preparing to use RWE more consistently, and whether the standards for RWE for payment and coverage will be similar or different from the standards for regulatory decisions; and
  • An industry perspective describing how industry is using RWE today, how this may or may not change due to the FDA framework, and how the framework will affect evidence development intended for other health care decision-makers.

SPEAKERS:

  • Jennifer Graff, PharmD, Vice President, Comparative Effectiveness Research, National Pharmaceutical Council
  • Brande Yaist, MHS, Senior Director, Center of Expertise in Global Patient Outcomes and Real-World Evidence, Eli Lilly and Company
  • Eleanor Perfetto, PhD, MS, Executive Vice President, Strategic Initiatives, National Health Council
  • Tricia Lee Wilkins, PharmD, MS, PhD, Director of Pharmacy Affairs, Academy of Managed Care Pharmacy

In the past few weeks, the FDA reopened the Framework for a Real-World Evidence Program; Availability comment period until April 16th. Read NPC's comment letter to the FDA on its RWE framework and check out the RWE section of our research library for more information.

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