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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.

Chair

Anjana Bose, PhD

Speaker

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



Speakers
AB

Anjana Bose

Director, Global Submissions, Certara/Synchrogenix, United States
With a career spanning over 30 years in the pharmaceutical industry, Dr. Bose has extensive experience across clinical development, data analytics, regulatory writing, and leadership role in regulatory submissions. During last 15 years, she has led New Drug Applications and Biologic... Read More →
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submission Leadership, Certara Synchrogenix, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →


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