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Session 6: Real World Evidence Framework
Session Chair(s)
Hayley Parker, PhD, MSc
Vice President Regulatory Affairs
PepGen, United States
Industry and regulators are striving to ensure patient needs and perspectives are included in the information provided to patients as well as in the information used to approve new products or expansion of labeling for approved products. How can industry Labeling Organizations facilitate the creation of label content generated from patient focus groups, RWE, and/or RWD? This session will provide insight as to how this can be done.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand requirements for the optimal labeling format for patient labeling
- Understand the definitions of Real-World Evidence (RWE) and Real-World Data (RWD), its history and evolving use along with the relevant guidances
- Identify examples of approved labeling using RWE
Speaker(s)
Real World Evidence and Real World Data
Denise Globe, MHS, PhD
Gilead Sciences, Inc., United States
Executive Director
Patient Experience in Oncology Product Labeling
Vishal Bhatnagar, MD
FDA, United States
(Acting) Director for Patient Outcomes, OCE, CDER
Real World Evidence: A Case Study
Thomas Kilker, MS
Jazz Pharmaceuticals , United States
Director and Interim Head, Regulatory Affairs Labeling