FDA/CMS Summit 2019

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