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Thursday, July 1 • 9:30am - 10:00am
#404 CH L: Speed to Submission: How Fast Can You Truly Go?

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Component Type: Workshop
Level: Advanced

Does your company get from database lock on the final clinical study to submission to a health authority in 3 months? 6 months? Longer? In this Content Hub, we'll discuss case studies to identify how to get your own duration closer to 3 months. Space is limited. When the virtual room is full, attendees attempting to access the session will receive a message noting that the session has reached maximum capacity.

Learning Objectives

Identify the three key stages on the critical path to submissions; Diagnose the critical path in a submission: For marketing submissions, clinical is typically the rate-limiting factor, but recognizing each piece of a critical path is critical; Share key pitfalls and strategies with their own teams: Participants will be able to speak to common pitfalls and strategies for addressing them.


Steve Sibley, MS

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 →

Thursday July 1, 2021 9:30am - 10:00am EDT
TBD Virtual Event Horsham, PA 19044