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Session 5: Case Studies from Recent Approvals of RWD/RWE Submissions
Session Chair(s)
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
Speaker(s)
CDER RWE Program: Update and Examples
Kimberly Smith, MD, MS
FDA, United States
Real-World Evidence Analytics Team, Office of Medical Policy, CDER
Oncology RWE Program: Overview and Regulatory Perspective on Effectiveness
Donna Rivera, PharmD, MSc
FDA, United States
Associate Director for Pharmacoepidemiology, OCE
FDA Accelerated Aproval Based on Real-World Evidence
Adrian Cassidy, PhD, MSc
Novartis, Switzerland
Head Global Evidence Generation