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Use of New Data Sources and Evidence Types for Regulatory Decision Making in Drug Development
Session Chair(s)
Anjana Bose, PhD
none
None, United States
This workshop will focus on the use of new data sources and evidence types to support regulatory applications and decision-making (e.g. real world evidence, post-authorization studies, patient-reported outcomes (PROs), digital/wearable technology, electronic health records, and historical control data) with specific emphasis on label expansion (new indications, expanded populations).
Learning Objective : Examine examples of recent approvals, new/extended indications, and expanded target patient populations; Identify opportunities to utilise real world data sources outside of routine clinical trials for expanded usage, support market access targeting specific subgroups of interest and overcome challenges to acceptability of alternative evidence for regulatory decision making.
Speaker(s)
Facilitator
Steve Sibley, MS
Certara , United States
Vice President, Global Submissions and Submissions Leadership
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