Overview
Short Course: October 22
Conference: October 25-26
In a market that is constantly adapting and adjusting to the needs of the healthcare field, real-world evidence (RWE) is increasingly becoming important for regulatory and reimbursement decision-making. RWE, in relation to the real-world data that is collected in combination with the advancement of artificial intelligence-based analytics platforms, 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. Historically used for post-market safety monitoring, RWE is now becoming integrated throughout the product development lifecycle. DIA’s Real-World Evidence Conference will explore new and innovative applications of RWE and deliver cutting-edge insights through successful use cases, case examples, and practical applications on how stakeholders are leveraging RWE to advance healthcare knowledge and decision-making.
Featured
Short Course or Primer
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Oct 22, 2021
Short Course 1: The Evolving Landscape of Real-World Data (RWD) and the Use of Pharmacoepidemiologic Methods and Machine Learning to Generate Credible Real-World Evidence (RWE)
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Who should attend?
Professionals involved in:
- Real-World Evidence
- Real-World Data
- Epidemiology
- Policy
- Regulatory Science
- Technology development
- Data analytics
- Clinical Research
Learning objectives
At the conclusion of this activity, participants should be able to:
- Explain how RWE is being used today to inform biopharmaceutic development across product lifecycle
- Discuss “lessons learned” from current uses of RWE by regulators, and how they can be applied for other future applications of RWE
- Recognize general considerations and key features of successful RWE studies acceptable to the regulators for effective decision-making
- Identify guidance and best practices for generating fit-for-purpose RWE for payers and HTA bodies
- Define the expanding applications of RWE to support clinical trials and evidence generation
- Evaluate the future applications of RWE in drug development
- Appraise how mobile technologies, artificial intelligence, machine learning, and other technologies are being used to generate RWE
- Evaluate how patient reported outcomes, electronic health records, and other patient data is expanding the resources for RWE
Program Committee
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TEST Paul Wong • Associate Director, Meeting Op
DIA, United States -
Brian Bradbury, DrSc, MA • Vice President, Center for Observational Research
Amgen, United States -
Dorothee Bartels, PhD, MSc • Chief Digital Officer
Aetion, Germany -
Paul M. Coplan, DrSc, MBA, MSc, FISPE • VP, Medical Device Epidemiology & Real-World Data Analytics
Johnson & Johnson, 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 -
James Harnett, PharmD, MS • Executive Director, Health Economics and Outcomes Research
Regeneron Pharmaceuticals, Inc. , 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 -
Sulabha Ramchandran, PhD, MS • Vice President and Head, US and Regions, Value Evidence and Outcomes
GlaxoSmithKline, United States -
Yun Lu, PhD, MS • Mathematical Statistician, Office of Biostatistics and Pharmacovigilance, CBER
FDA, United States
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Preconference Short Courses
Additional Information
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Real-World Evidence Conference Resource Kit
