FDA/CMS Summit | Expanding the Role of RWE and PROs in Regulatory Decision-Making

At the FDA/CMS Summit on Tuesday, December 3, NESTcc Data Network Director Robert Zusterzeel, MD, PhD, MPH, joins a panel session titled Expanding the Role of RWE and PROs in Regulatory Decision-Making.

Panel Summary

Moderator

  • Cathy W. Critchlow, PhD
    Vice President, Center for Observational Research
    Amgen, Inc.

Panelists

  • David Martin
    Associate Director, Real World Evidence Analytics,
    Office of Medical Policy, CDER
    U.S. Food and Drug Administration (FDA)
  • Karin Van Baelen
    Head, Global Regulatory Affairs
    Janssen, Pharmaceutical Companies of Johnson & Johnson
  • Robbert Zusterzeel, MD, PhD, MPH
    Data Network Director
    NEST Coordinating Center (NESTcc)
  • James Reimann
    Vice President, Global Head Oncology, Biostatistics
    Genentech

Location:

Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203


Registration:

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.@MedTechStrat shares NESTcc Test-Case insights from @JNJMedDevices and Network Collaborator @LaheyHealth in Market Pathways article: "Real-World Evidence and Johnson & Johnson: NESTcc Unlocking Doors to Medical Device Innovation and Collaboration." Read: bit.ly/32Bkwgu 18 hours ago

Developed by expert subcommittees, the NESTcc Data Quality and Methods Frameworks serve as guides for medical device ecosystem stakeholders to ensure data quality and research methodologies in #realworldevidence studies. Learn more: bit.ly/2wL6FYU pic.twitter.com/8trkWqzi3o 2 days ago

National Evaluation System for health Technology Coordinating Center (NESTcc)
1501 Wilson Blvd., Suite 910, Arlington, VA 22209

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