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Hyatt Regency Cambridge

Nov 14, 2019 7:30 AM - Nov 15, 2019 12:30 PM

575 Memorial Drive, Cambridge, MA 02139

Real World Evidence Conference

How Real World Evidence can be used for regulatory purposes

Session 5: Use of Real World Evidence to Support Regulatory Decision Making for Medical Devices

Session Chair(s)

Paul M. Coplan, DrSc, MBA, MSc, FISPE

Paul M. Coplan, DrSc, MBA, MSc, FISPE

VP, Medical Device Epidemiology & Real-World Data Analytics

Johnson & Johnson, United States

This session will provide an update on the use of RWE for regulatory decisions for medical devices. Current plans and activities within the FDA’s Center for Devices and Radiological Health (CDRH) involving RWE will be presented by a CDRH speaker, including the parallel review program by CDRH for regulatory approval and Centers for Medicaid and Medicare Services (CMS) for coverage decisions. The session will assess methodological challenges with using RWE for regulatory decisions and work that the National Evaluation System for Health Technology (NEST) is doing to improve the methodology. The session will also address innovative developments of RWE within medical device companies and explore whether these can be used for regulatory decisions.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Discuss informed assessments of how RWE may be used for regulatory decisions
  • Design and evaluate RWE strategies for medical devices for regulatory decisions
  • Understand the trends and opportunities in research using RWE to evaluate medical devices


Daniel  Caños, PhD, MPH

A Multistakeholder Community Approach for Leveraging RWE

Daniel Caños, PhD, MPH

FDA, United States

Deputy Director, CDRH

Sharon-Lise  Normand, PhD

Methodological Framework for Medical Device Studies Based on RWE

Sharon-Lise Normand, PhD

Harvard Medical School, United States

Professor of Health Care Policy (Biostatistics)

Paul M. Coplan, DrSc, MBA, MSc, FISPE

Use of Healthcare Databased for Medical Device Assessment

Paul M. Coplan, DrSc, MBA, MSc, FISPE

Johnson & Johnson, United States

VP, Medical Device Epidemiology & Real-World Data Analytics

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