Overview
Within the past few years there has been a lot of discussion on the generation and utilization of real world evidence (RWE). It is well-known that regulators use RWE to monitor post-market safety and to make regulatory decisions, Sponsors utilize it to support both clinical trial design and observational studies to generate treatment approaches, and healthcare systems collect and use RWE to substantiate coverage decisions. However, what are the ‘new and innovative’ RWE applications in today’s healthcare ecosystem? This conference will explore examples of unique applications of RWE, and describe novel ways stakeholders are leveraging RWE to advance healthcare knowledge and decision-making.
Featured
Who should attend?
Professionals involved in:
- Real World Evidence
- Epidemiology
- Policy
- Regulatory Science
Learning objectives
At the conclusion of this conference, participants should be able to:
- Explain how RWE can facilitate clinical trial design
- Describe criteria in which RWE has been used for label expansion and discuss future applications
- Discuss appropriate uses for patient generated health data
- Identify areas where medical devices have successfully used RWE for regulatory decision-making
Program Committee
-
Jeff Allen, PhD • President and Chief Executive Officer
Friends of Cancer Research, United States -
Brian Bradbury, DrSc, MA • Vice President, Center for Observational Research
Amgen, United States -
Paul M. Coplan, DrSc, MBA, MSc, FISPE • VP, Medical Device Epidemiology & Real-World Data Analytics
Johnson & Johnson, United States -
Jacqueline A. Corrigan-Curay, JD, MD • Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER)
FDA, United States -
Nancy Dreyer, PhD, MPH, FISPE • President
Dreyer Strategies LLC, United States -
Marni Hall, PhD, MPH • Vice President, Regulatory Science and Strategy
IQVIA, United States -
James Harnett, PharmD, MS • Executive Director, Health Economics and Outcomes Research
Regeneron Pharmaceuticals, Inc. , United States -
Sophie Janssens • Vice President, Global Head of Real World Evidence
UCB Pharma, Inc, Belgium -
Gabriela Lavezzari, PhD, MBA • Senior Director, US R&D Policy and Scientific Affairs
GlaxoSmithKline, United States -
Debra Schaumberg, DrSc, MPH • Vice President, Epidemiology & Head Strategic and Scientific Affairs
Evidera | PPD, United States -
Mark Stewart, PhD • Vice President, Science Policy
Friends of Cancer Research, United States
