[DIA Europe 2023] Use of RWE/RWD in Regulatory and HTA For Early Access Medicine

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Presented by

Tina Wang, CIRS; Claus Bolte, Swissmedic; Stephen Duffield, NICE; Alex Simpson, Roche; Valentina Strammiello, EPF.

About this talk

The developing data landscape is changing both the way medicines are being developed and their continuous assessment. Real-world data/evidence (RWD/RWE) can bring value to every stage of a drug’s life cycle.This session provides an overview of how RWE has been used by regulatory and HTA agencies at pre and post approval stages; explores through case studies how RWD/RWE has or could be used in the review and reimbursement for rare diseases/early access medicines; discusses the use of RWD as part of integrated evidence generation plans by companies through lifecycle of medicines;, as well as the challenges that companies and agencies face in ensuring that RWD/RWE is fit for purpose.
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