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Real-World Evidence Throughout the Product Life Cycle: Case Studies and Real-Life Examples
Session Chair(s)
Representative Invited
European Medicines Agency, Netherlands
Use of 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 : Understand the use of RWE to support regulatory decisions; Appreciate use cases depending on regulatory assessment, stage of lifecycle and therapeutic area; Learn from examples of RWE use; Bring the perspective of different stakeholders on these regulatory use cases.
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