FREE WEBINAR: Accelerating Submissions: Understanding FDA’s NDA Data Submission Requirements and Developing Biometrics-focused Strategies to Reduce Costs and Save Time

 

Click to Watch the Recording

• Date: Tuesday, February 6, 2024
• Time: 10:00 a.m. · Seoul (GMT +9:00)
• Webinar description:
  • 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

 

Short overview of presenter’s experience:

• Amanda Cross; COO
  • 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.

 

https://www.bigmarker.com/bioforum-the-data-masters/Accelerating-Submissions-Understanding-FDA-s-NDA-Data-Submission-Requirements-and-Developing-Biometrics-focused-Strategies-to-Reduce-Costs-and-Save-Tim