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Overview

Short Courses: November 8
Conference: November 9-10

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.

While we work on the agenda for 2020, please view our 2019 Final Program to see the topics presented.

Who should attend?

Professionals from industry, academia, and government involved in all phases of the medical product lifecycle including:

  • Real World Evidence
  • Epidemiology
  • Policy
  • Regulatory Science
  • Technology development
  • Data analytics
  • Clinical Research

Learning objectives

At the completion of this forum, the participant should be able to:
  • Explain 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
  • Describe the most common designs using Master Protocols and their utility in solving clinical development challengess

Program Committee

  • Nancy A. Dreyer, PhD, MPH, FISPE
    Nancy A. Dreyer, PhD, MPH, FISPE Chief Scientific Officer and Senior Vice President
    IQVIA, United States
  • Steven A. Anderson, PhD
    Steven A. Anderson, PhD Director, Office of Biostatistics and Epidemiology, CBER
    FDA, United States
  • Brian D. Bradbury, PhD, MA
    Brian D. Bradbury, PhD, MA Vice President, Center for Observational Research
    Amgen, Inc., United States
  • Paul M. Coplan, MBA, FISPE
    Paul M. Coplan, MBA, FISPE Vice President, Medical Device Epidemiology & Real-World Data Analytics
    Johnson & Johnson, United States
  • Marni  Hall, PhD, MPH
    Marni Hall, PhD, MPH Vice President, Clinical Evidence
    IQVIA, United States
  • James  Harnett, PharmD, MS
    James Harnett, PharmD, MS Senior Director, Lead, Real World Data and Analytics, Patient and Health Impact
    Pfizer Inc., United States
  • Jingyu (Julia)  Luan, PhD
    Jingyu (Julia) Luan, PhD Regulatory Affairs Director, BioPharmaceuticals R&D, Late-stage Development, CRM
    AstraZeneca, United States
  • David  Martin, MD, MPH
    David Martin, MD, MPH Associate Director for Real World Evidence Analytics, OMP, CDER
    FDA, United States
  • David  Miller
    David Miller Global Head of Real World Evidence Methods, Analytics and Safety
    UCB Pharma, Inc., United States
  • Robert  Reynolds, FISPE
    Robert Reynolds, FISPE Vice President, Epidemiology
    GlaxoSmithKline, United States
  • Debra  Schaumberg, MPH
    Debra Schaumberg, MPH Vice President, Scientific Affairs Real World Evidence
    Evidera, United States
  • Mark  Stewart, PhD
    Mark Stewart, PhD Vice President, Science Policy
    Friends of Cancer Research, United States
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