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Accelerating FDA Submissions: Understanding New Drug Application Requirements and Developing Biometrics-Focused Strategies to Reduce Costs and Save Time
About This Webinar
Join Amanda Cross, Bioforum’s Chief Operating Officer, to learn how a data-first approach to outsourcing can speed your FDA submission timelines.
Agenda
- An overview of the Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS)
- Requirements for FDA data submission packages
- ISS/ISE data integration strategies and risk mitigation
- Reducing costs and regulatory submission timelines with centralized biometrics
- Keys to successfully implementing a biometrics-focused clinical development business model
Who can view: Everyone
Webinar Price: Free
Featured Presenters
COO, Bioforum
Amanda has over 25 years of operational and commercial experience in the clinical trial industry at both pharmaceutical companies and CROs, with a particular focus on biometrics. An accomplished leader with a background in statistics, she brings broad experience in data acquisition, refinement, analysis, and reporting, and specializes in optimizing processes, crafting cost-effective solutions, and prioritizing data quality.
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