Wednesday, June 27 • 3:15pm - 4:00pm
#380: Use of New Data Sources and Evidence Types for Regulatory Decision Making in Drug Development

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Component Type: Workshop
Level: Intermediate

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 Objectives

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.


Anjana Bose, PhD


Use of New Data Sources and Evidence Types for Regulatory Decision Making in Drug Development
Steve Sibley, MS


Anjana Bose

Associate Principal Regulatory Writer, Synchrogenix
Dr. Bose is experienced in clinical development and biometrics. She has contributed to many successful regulatory submissions in the US. She has collaborated with multiple partner companies in Europe in preparation of protocols, statistical analysis plans, study reports, integrated... Read More →

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Synchrogenix, a Certara Company
With a career spanning more than 25 years in the pharmaceutical industry, Mr. Sibley has extensive regulatory writing experience across Modules 1-5, with project and team leadership roles on more than 50 submissions. His experience is truly global, having worked in project teams encompassing... Read More →

Wednesday June 27, 2018 3:15pm - 4:00pm
E and E Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA