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2023 RF Quarterly Q1

RF Quarterly,  March 2023
Patient-focused regulatory practice

Welcome to the March issue of RF Quarterly, which takes a look at patient-focused regulatory practice and includes articles on patient-reported outcomes in regulatory decision making; real-world evidence and postmarket surveillance data; generating evidence for racial and ethnic minorities in oncologic drug development; structured, patient-focused benefit-risk assessment; and the role of the high-performance integrated virtual in research using patient-generated data.

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Table of Contents

1    Introduction
          Flora Sandra Siami, MPH   •  Stephen C. Weber, MD
4   The evolution and use of patient-reported outcomes
      in regulatory decision making
         Stephen C. Weber, MD
11  Real-world evidence and postmarket surveillance data: Are they the same thing?
           Kasey Sands, PhD, MSN, RN • Joy Frestedt, PhD, CPI, RAC, FRAPS, FACRP
23  Generating evidence for racial and ethnic minorities during development of oncologic therapeutics
           Lola Fashoyin-Aje, MD, MPH • Lea Ann Browning-McNee, MS •
           Jessica Boehmer, MBA • Richard Pazdur, MD • Susan C. Winckler, RPh, Esq
31  Industry implementation of structured, patient-focused benefit-risk assessment
           Charles Garrigan, MS, MBA  • Bennett Levitan, MD, PhD

43  Enhancing collaboration, access, and research using patient-generated data
           Laura E. Gressler, MS, PhD • Art Sedrakyan, MD, PhD

Upcoming in RF Quarterly during 2023 
  • Global health and regulatory authorities (June)
  • Leadership (September; print issue to 2023 Convergence)
  • 2023 RAPS Convergence (December)
Previous issues
Access more benefits in the former Article Series  on the following topics:
  • Regulatory Intelligence
  • The Shifting Global Regulatory Landscape
  • Global Regulatory Strategies and Best Practices
  • The Strategic Role of the Regulatory Professional
  • Risk Management and Quality
  • Global Strategies for Drugs and Devices
  • Executive Leadership and Management
  • Global Regulatory Policy and Strategy

To contribute, email Renee Matthews, Senior Editor, at rmatthews@raps.org

For more information, see: Guidelines for Authors • 2023 Editorial Calendar

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