June 18, 2024 | RWE, eca, external control arms, real-world evidence, regulatory
This webinar reviews considerations for the design and data selection for RWE studies, including external control arm studies, to meet regulatory and HTA needs.
Regulators and agencies responsible for market authorization and health technology assessment (HTA) are increasingly using real-world evidence (RWE) to enhance their decision-making. Life sciences companies must ensure that data utilized for RWE generation is considered fit-for-purpose.
Focusing on an external control arm (ECA) use case, we will share lessons learned highlighting the advantages of a data-agnostic approach to data selection, understanding regulatory and HTA expectations, and obtaining diverse stakeholder insights. The audience will gain appreciation for considering multiple perspectives, including regulators, HTAs and payers, when evaluating data and planning for RWE submissions.
Of interest to all those interested in: pharmacoepidemiology, RWE, market access, manufacturers, biotech, data vendors.
This content was provided by Genesis Research Group
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