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Real-World Evidence Throughout the Product Life Cycle: Case Studies and Real-Life Examples
Session Chair(s)
Denise Umuhire, MBA, MSC
Pharmacoepidemiologist and Real-World Evidence Specialist
European Medicines Agency, Netherlands
Use of Real-World Evidence (RWE) in regulatory assessments has increased in recent years with use cases spanning across the development, initial authorisation and post-marketing monitoring of medicines. Examples across lifecycle and therapeutic areas will be discussed.
Learning Objective : Discuss the use of RWE to support regulatory decisions; Identify use cases based on regulatory assessment, stage of lifecycle and therapeutic area; Examine real-world examples of RWE use to identify effective practices and apply insights to future evidence-generation strategies.
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