Overview

Global health authorities will move away from unstructured submissions and toward a structured format for data and content. Using structured data from source to submission eliminates manual transcription, aggregation, and data table creation. This reduces resource needs, reduces errors, accelerates filing readiness, and supports initiatives like the ISPE Pharma 4.0 initiative to provide structured data using digitalization and automation.

In this webinar, we will discuss:

• Enabling structured submissions with structured data
• Automating data table generation to reduce resource needs
• Integrating end-to-end workflow of data from source to submission
• Managing the large data sets of Module 3
• Supporting Pharma 4.0 unified data model