How Companies Are Using Real-World Evidence for Regulatory Purposes

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.

Moderator:

Cerise James, MD, MPH

Principal, Tilghman James Group

Speaker:

Neil A. Belson, JD, MS

Owner, Law Office of Neil A. Belson, LLC