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:

Follow us @NESTccMedTech

Today at 4:30 p.m. CT, NESTcc Chief of Staff @RachelRRath will present at the 5th Annual Evening of Pediatric Device Innovation, joining experts from Houston and across the country to discuss real world evidence (RWE). More: bit.ly/2DRlny0 pic.twitter.com/v5rhJ1qZBU 2 days ago

At the FDA/CMS Summit today at 4:30 p.m., join Data Network Director @robbert_z for a panel discussion on expanding the role of real-world evidence and patient-reported outcomes in regulatory decision-making. #RWE More: bit.ly/360vmgv pic.twitter.com/DcGyCnCCOD 4 days ago

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

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