Menu
×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
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:
-
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
-
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
-
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
Featured
Short Course or Primer
-
Nov 07, 2022
Short Course: How Good is Good Enough? Fit-for-Purpose Considerations for RWD/RWE for Regulatory Purposes
Learn more
Program Committee
-
Brian Bradbury, DrSc, MA • Vice President, Center for Observational Research
Amgen, United States -
John Concato, MD, MPH, MS • Associate Director for Real-World Evidence Analytics, OMP, CDER
FDA, United States -
Simon Dagenais, PhD, MSc • Senior Director, RWE Center of Excellence
Pfizer Inc, United States -
Marni Hall, PhD, MPH • Vice President, Regulatory Science and Strategy
IQVIA, 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 -
Yun Lu, PhD, MS • Mathematical Statistician, Office of Biostatistics and Pharmacovigilance, CBER
FDA, United States -
Jingyu (Julia) Luan, PhD • Senior Director, Global Regulatory Affairs, BioPharmaceuticals R&D
AstraZeneca, United States -
David Martin, MD, MPH • Vice President, Clinical Safety and Risk Management
Moderna, United States -
Delphine Saragoussi, MD, MSc • Executive Director, Real-World Evidence
PPD, Part of Thermo Fisher Scientific, France -
Mark Stewart, PhD • Vice President, Science Policy
Friends of Cancer Research, United States
Contact us
Registration Questions?
PRECONFERENCE SHORT COURSES
How Good is Good Enough? Fit-for-Purpose Considerations for RWD/RWE for Regulatory PurposesAdditional Information
Live Meeting PoliciesDiscover DIA’s Live In-Person Events
Real-World Evidence Conference Meeting Resource Kit
