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Can You Complete Your Submission in 10 weeks?
Session Chair(s)
Steve Sibley, MS
Vice President, Global Submissions and Submissions Leadership
Certara, United States
Drug development teams are being expected to deliver marketing applications in record time, despite increased complexity. This workshop is designed to give participants first-hand experience in such a submission.
Learning Objective : Recognize key factors that must be identified proactively to ensure creation of a submission timeline that is both expedited and feasible; Diagnose the critical path and rate-limiting components in the plan, and learn ways of mitigating the risks of those components; Demonstrate the ability to adjust to changes and embrace scenario-planning when faced with uncertainty.
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