Connect with Us
602 Park Point Drive, Suite 225, Golden, CO 80401 – +1 303.495.2073
© 2024 Medical Affairs Professional Society (MAPS). All Rights Reserved Worldwide.
Objectives:
Product Developers are using Real-World Evidence (RWE) for regulatory purposes in an expanding range of contexts. Drug sponsors are directly using RWE as an external control arm in clinical trials. Companies also use RWE to obtain label expansions and to satisfy post-market approval requirements. RWE is also being used to help design traditional clinical studies, to help select clinical trial sites and identify study endpoints. This presentation looks at different regulatory contexts in which product developers are using RWE.
