Regulatory, Quality and Good Manufacturing Practices

Expanding Use of and Access to Real World Evidence

Thursday, September 30, 2021

10:00 AM – 10:50 AM ET

Location: Virtual

Virtual Moderator(s)

Diane Wurzburger, JD

Executive, RAQA Developed Markets & Global Regulatory Policy
GE Healthcare

Virtual Speaker(s)

Heather M. Colvin, MPP

Director, Evidence & Outcomes Policy
Johnson & Johnson
Danelle Miller, JD

Vice President, Global Regulatory Policy & Intelligence
Roche Diagnostics
Wendy Rubinstein, MD, PhD

Director, Personalized Medicine; Deputy Office Director
CDRH/FDA
Flora Sandra Siami, MPH

Senior Vice President, NESTcc
Medical Device Innovation Consortium (MDIC)

As FDA continues to advocate for the Agency and manufacturers to have better access to real world evidence (“RWE”), new data streams are coming online and use cases have been made public. During this session, experts within the medical device community will provide an overview of new and enhanced resources that enable the use of RWE, as well as how that information is being used in FDA regulatory decision-making.