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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

Overview

Short Course: November 13
Conference: November 14-15

Real world evidence (RWE) is increasingly becoming important for regulatory decision-making and beginning to touch all areas of the healthcare value chain. Historically used for post-market safety monitoring, sponsors are now beginning to use RWE to support clinical trial design and observational studies in order to generate better treatment approaches, while healthcare systems are collecting and using RWE to substantiate coverage decisions. DIA’s Real World Evidence Conference will explore new and innovative applications of RWE, and deliver cutting-edge insights in how stakeholders are leveraging RWE to advance healthcare knowledge and decision-making.

Need approval in order to attend?

Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.

Preconference Short Course

Introduction to Real World Data for Data Geeks


Check out our 2019 Program!


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Continuing Education

Exhibits

Highlights & Features

Who should attend?

Professionals involved in:

  • Real World Evidence
  • Epidemiology
  • Policy
  • Regulatory Science
  • Technology Development
  • Data Analytics
  • Clinical Research

Learning objectives

At the conclusion of this activity, participants should be able to:
  • Discuss how RWE is being used today to inform biopharmaceutic development across product lifecycle
  • Describe the recent FDA strategic framework for RWD in regulatory decisions
  • Evaluate the future applications of RWE in drug development
  • Appraise how mobile technologies, AI, machine learning, and other technologies are being used to generate RWE
  • Evaluate how patient reported outcomes, EHR, and other patient data is expanding the resources for RWE
  • Discuss “lessons learned” from current uses of RWE, and how these can be applied for other future applications of RWE

Short Course or Primer

To keep you at the forefront.

Nov 13, 2019

Short Course:

Introduction to Real World Data for Data Geeks

Program Committee

  • Robert  Suruki
    Robert Suruki RWE Strategy Lead, Immunology
    UCB Pharma, Inc., Belgium
  • Bart  Barefoot, JD
    Bart Barefoot, JD Head, Europe Regulatory Policy
    GSK, United Kingdom
  • Brian  Bradbury, DrSc, MA
    Brian Bradbury, DrSc, MA Vice President, Center for Observational Research
    Amgen, United States
  • 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
  • Jacqueline A. Corrigan-Curay, JD, MD
    Jacqueline A. Corrigan-Curay, JD, MD Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER)
    FDA, United States
  • Nancy A Dreyer, PhD, MPH, FISPE
    Nancy A Dreyer, PhD, MPH, FISPE Founder
    Dreyer Strategies LLC, United States
  • Marni  Hall, PhD, MPH
    Marni Hall, PhD, MPH Vice President and General Manager, Global Regulatory Science and Strategy
    IQVIA, United States
  • James  Harnett, PharmD, MS
    James Harnett, PharmD, MS Executive Director, Health Economics and Outcomes Research
    Regeneron Pharmaceuticals, Inc. , United States
  • Debra  Schaumberg, DrSc, MPH
    Debra Schaumberg, DrSc, MPH Vice President and Global Head, Startegic Development Consulting Chair
    Evidera | PPD, United States
  • Mark  Stewart, PhD
    Mark Stewart, PhD Vice President, Science Policy
    Friends of Cancer Research, United States

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