Description
This training outlines the importance of data standards and where to find regulatory submission requirements across the globe. It also details the FAIR Data Principles. The training further explains the FDA's guidance and supporting documents, including the Data Standards Catalog. The module concludes by discussing the requirements for regulatory submission to NMPA, EMA, and MFDS.
Learning Outcomes
At the end of this module, learners will be able to:
- Understand why standards are important
- Identify the documents that describe FDA’s requirements
- Locate submission requirements for other geographies and regulatory agencies
Language: English | Duration: 00:43:54 | CEUs: 0.1
Available Sessions:
Product Name
Date
Region
Time
Price
SDTM in Action Module 14: SDTM Regulatory Overview
Online (self-paced)
On-Demand, Self-Paced Online
$249.00
| Product Name | Date | Region | Time | Price | |
| SDTM in Action Module 14: SDTM Regulatory Overview | Online (self-paced) | On-Demand, Self-Paced Online | $249.00 |