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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

Session 5: Case Studies from Recent Approvals of RWD/RWE Submissions

Session Chair(s)

Yun  Lu, PhD, MS

Yun Lu, PhD, MS

Mathematical Statistician, Office of Biostatistics and Pharmacovigilance, CBER

FDA, United States

Session 5: Case Studies from Recent Approvals of RWD/RWE Submissions

Learning Objective : At the conclusion of this session, participants should be able to:
  • Explore FDA and pharmaceutical industry perspectives on the potential role of RWE in regulatory decision-making
  • Identify relevant considerations for the use of RWD and RWE to support regulatory decision-making
  • Apply lessons learned from recent use cases including submissions containing RWE to support safety and effectiveness


Kimberly  Smith, MD, MS

CDER RWE Program: Update and Examples

Kimberly Smith, MD, MS

FDA, United States

Real-World Evidence Analytics Team, Office of Medical Policy, CDER

Donna  Rivera, PharmD, MSc

Oncology RWE Program: Overview and Regulatory Perspective on Effectiveness

Donna Rivera, PharmD, MSc

FDA, United States

Associate Director for Pharmacoepidemiology, OCE

Adrian  Cassidy, PhD, MSc

FDA Accelerated Aproval Based on Real-World Evidence

Adrian Cassidy, PhD, MSc

Novartis, Switzerland

Head Global Evidence Generation

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