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Overview

Short Course | November 7

Conference | November 10-11

In a market that is constantly adapting and adjusting to the needs of the healthcare field, real-world evidence (RWE) is becoming increasingly important for regulatory and reimbursement decision-making. Historically used for post-market safety monitoring, RWE is now integrated throughout the product development lifecycle, and has led to the real-time analysis of data to better understand and gain insights on disease, approaches to treatment, and how to substantiate coverage decisions.

DIA’s Real-World Evidence Conference will explore new, innovative applications of RWE, and deliver cutting-edge insights to leverage this knowledge to advance healthcare decision-making.

Testimonial:

“DIA’s Real-World Evidence Conference on Nov 10-11 is the single best place to learn about new developments in how RWE is being used for regulatory purposes. You will hear from the regulators themselves and learn about positive regulatory decisions enabled by RWE in the US and Europe as well as challenges encountered.” Nancy Dreyer, Principal, Dreyer Strategies; Chief Scientific Officer Emerita, RW Strategies, IQVIA

Dreyer



  • Event Goals and Offerings

    • Define key recent events related to RWE in the past year (2021-2022)
    • Recognize the role of Prescription Drug User Fee Act (PDUFA) in evolving RWE regulatory landscape
    • Interpret and apply newly published guidance documents from US FDA and EMA RWE to regulated product development
    • Recognize how regulatory agencies and health technology organizations support research and related initiatives.
    • Recognize how real-world data can be used to assist in study design and as a data source to facilitate clinical research
    • Recognize the regulatory and clinical development context that made an RWE-enabled development strategy attractive in each case
    • Identify key aspects of real-world data that can have an impact on data quality and approaches to addressing these factors
    • Recognize future opportunities to leverage RWD and RWE in generating RWE for regulatory decision-making
    • View Agenda



  • Why You Can’t Miss It

    • Network with like-minded professionals focused on real-world data and real-world evidence to discuss best practices and lessons learned
    • Learn how to apply successful use cases, real-world examples, and practical outcomes into your own company or organization
    • Gain insights and discuss how stakeholders are impacted by real-world data and real-world evidence
    • Evaluate future applications of real-world evidence in drug development, clinical trials, and evidence generation
    • Register Now







  • Learning Objectives

    At the conclusion of this activity, participants should be able to:

    • Identify key events related to RWE in the past year and how these events are interrelated and contribute to its advancement
    • Recognize the role of Prescription Drug User Fee Act (PDUFA) in evolving RWE regulatory landscape
    • Interpret and apply newly published guidance documents from US FDA and EMA RWE to regulated product development
    • Recognize how regulatory agencies and health technology organizations support research and related initiatives
    • Recognize how real-world data can be used to assist in study design and as a data source to facilitate clinical research
    • Recognize the regulatory and clinical development context that made an RWE-enabled development strategy attractive
    • Identify key aspects of real-world data that can have an impact on data quality and approaches to addressing these factors
    • Recognize future opportunities to leverage RWD and RWE in generating RWE for regulatory decision-making
  • Meeting Designed For

    Join professionals from every corner of the vast realm of real-world data and real-world evidence:

    • Academia
    • Clinical Research
    • Data analytics
    • Epidemiology
    • Health Economics and Outcomes Research
    • Pharmacovigilance
    • Policy
    • Real-World Evidence
    • Real-World Data
    • Regulatory Science
    • Technology development
    • Register Now



Program Committee

  • Brian  Bradbury, DrSc, MA
    Brian Bradbury, DrSc, MA Vice President, Center for Observational Research
    Amgen, United States
  • John  Concato, MD, MPH, MS
    John Concato, MD, MPH, MS Associate Director for Real-World Evidence Analytics, OMP, CDER
    FDA, United States
  • Simon  Dagenais, PhD, MSc
    Simon Dagenais, PhD, MSc Senior Director, RWE Center of Excellence
    Pfizer Inc, United States
  • Marni  Hall, PhD, MPH
    Marni Hall, PhD, MPH Vice President, Regulatory Science and Strategy
    IQVIA, United States
  • Brad  Jordan, PhD
    Brad Jordan, PhD Senior Director, Head of Regulatory Affairs Policy
    Flatiron Health, United States
  • Nirosha M. Lederer, PhD, MS
    Nirosha M. Lederer, PhD, MS Head, US Government Partnerships; Senior Director, RWE Strategy
    Aetion, United States
  • Yun  Lu, PhD, MS
    Yun Lu, PhD, MS Mathematical Statistician, Office of Biostatistics and Pharmacovigilance, CBER
    FDA, United States
  • Jingyu (Julia)  Luan, PhD
    Jingyu (Julia) Luan, PhD Senior Director, Global Regulatory Affairs, BioPharmaceuticals R&D
    AstraZeneca, United States
  • David  Martin, MD, MPH
    David Martin, MD, MPH Vice President, Clinical Safety and Risk Management
    Moderna, United States
  • Delphine  Saragoussi, MD, MSc
    Delphine Saragoussi, MD, MSc Executive Director, Real-World Evidence
    Evidera, Part of Thermo Fisher Scientific, France
  • Mark  Stewart, PhD
    Mark Stewart, PhD Vice President, Science Policy
    Friends of Cancer Research, United States
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