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Renaissance Baltimore Harborplace Hotel

Oct 16, 2023 7:30 AM - Oct 17, 2023 6:30 PM

202 E Pratt Street, Baltimore, MD 21202, USA

Real-World Evidence Conference

Translating Insights into Real-World Value

Overview

Short Course: October 12 | Virtual

Short Course: October 13 | Virtual

Conference: October 16-17 | In-Person

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.


Participant Testimonials

“DIA RWE is the best RWE-related event I've attended - it has compelling speakers, strong education opportunities, and a great collective of attendees.” - Nicholaas Honig, JD, Associate Regulatory Counsel, Aetion

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.


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Highlights & Features

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Discover Baltimore!

Today’s Baltimore is a place where good ideas and ambition are the currency that matter most. It’s a place where art is seen as a catalyst for conversation, food as a means of connection, and history as an opportunity for education. It’s an essential destination full of inclusive neighborhoods where all visitors will feel invited, welcomed, and seen.
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Welcome Video!

Hear what our Chair David Martin, MD, MPH has to say about Real-world Evidence!
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Who should attend?

  • 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


    • Learning Objectives

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

      • Identify key events related to RWE in the past 1 year period
      • Compare various data standards used for the analysis and submission of real-world data
      • Evaluate how external control arm data can be used to inform early decisions in drug development programs
      • Explain the methodological approaches underlying tokenization
      • Describe key consideration for the use of RWD and RWE to support regulatory decision-making and apply lessons learned from recent use cases (recent approvals of RWD/RWE submissions)
      • Identify how to utilize clinical notes to create a representative natural language processing (NLP) training sample
      • Explain the need for collaborative studies to address a lack of harmonization on RWD/E methodologies and quality
      • Recognize trends in clinical post-marketing commitments (PMC) and requirements (PMR) issued by US FDA in oncology and how RWE can be applied

        • Register



    Short Course or Primer

    To keep you at the forefront.

    Oct 12, 2023

    Short Course:

    How Good is Good Enough? Fit-for-Purpose Considerations for RWD/RWE for Regulatory Purposes

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    Oct 13, 2023

    Short Course:

    Measuring the Quality of Real-World Data (RWD)

    Learn more

    Program Committee

    • David Martin, MD, MPH
      David Martin, MD, MPH Vice President, Head, PCO Center of Excellence
      Novartis, 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 Real-World Evidence Lead, Internal Medicine
      Pfizer Inc, United States
    • Rachele Hendricks-Sturrup, DrSc, MA, MSc
      Rachele Hendricks-Sturrup, DrSc, MA, MSc Research Director, Real-World Evidence
      Duke-Robert J. Margolis, MD, Institute For Health Policy, United States
    • Brad Jordan, PhD
      Brad Jordan, PhD Associate Vice President, Regulatory Policy and Strategy
      Eli Lilly and Company, United States
    • Nirosha M. Lederer, PhD, MS
      Nirosha M. Lederer, PhD, MS Head, US Government Partnerships; Senior Director, RWE Strategy
      Aetion, United States
    • Charles Lee, MBA, MS
      Charles Lee, MBA, MS Executive Regulatory Science Director
      AstraZeneca, United States
    • Yun Lu, PhD, MS
      Yun Lu, PhD, MS Deputy Division Director, DABRA, OBPV, CBER
      FDA, United States
    • Sarah K Martin, PhD, MS
      Sarah K Martin, PhD, MS Senior Director - Global Regulatory Policy (Oncology)
      Eli Lilly & Co., United States
    • Brittany Avin McKelvey, PhD
      Brittany Avin McKelvey, PhD Director, Regualtory Affairs
      Friends of Cancer Research, United States
    • Keri Monda, PhD, MS
      Keri Monda, PhD, MS Executive Director, Center for Observational Research
      Amgen, United States
    • Representative Invited
      Representative Invited Irish Dental Association, Ireland

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    DIA Learning: eLearning Soultions
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