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.
Featured
Short Course or Primer
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Oct 12, 2023
Short Course: How Good is Good Enough? Fit-for-Purpose Considerations for RWD/RWE for Regulatory Purposes
Learn more -
Oct 13, 2023
Short Course: Measuring the Quality of Real-World Data (RWD)
Learn more
Who should attend?
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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
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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
Discover Baltimore!
Welcome Video!
Program Committee
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David Martin, MD, MPH • Vice President, Global Head RWE
Moderna, United States -
John Concato, MD, MPH, MS • Associate Director for Real-World Evidence Analytics, OMP, CDER
FDA, United States -
Simon Dagenais, PhD, MSc • Real-World Evidence Lead, Internal Medicine
Pfizer Inc, United States -
Rachele Hendricks-Sturrup, DrSc, MA, MSc • Research Director, Real-World Evidence
Duke-Robert J. Margolis, MD, Center for Health Policy, United States -
Brad Jordan, PhD • Senior Director, Head of Regulatory Affairs Policy
Flatiron Health, United States -
Nirosha M. Lederer, PhD, MS • Head, US Government Partnerships; Senior Director, RWE Strategy
Aetion, United States -
Charles Lee, MBA, MS • Executive Regulatory Science Director
AstraZeneca, United States -
Yun Lu, PhD, MS • Mathematical Statistician, Office of Biostatistics and Pharmacovigilance, CBER
FDA, United States -
Sarah Martin, PhD, MS • Senior Director - Global Regulatory Policy (Oncology)
Eli Lilly & Co., United States -
Brittany McKelvey, PhD • Director, Regualtory Affairs
Friends of Cancer Research, United States -
Keri Monda, PhD, MS • Executive Director, Center for Observational Research
Amgen, United States -
Representative Invited • DIA, United States
Contact us
Registration Questions?
PRE-CONFERENCE SHORT COURSES
How Good is Good Enough? Fit-for-Purpose Considerations for RWD/RWE for Regulatory Purposes
Measuring the Quality of Real-World Data (RWD)
Additional Information
Discover DIA’s Live In-Person Events
Download and fill out our Justification Letter
