eSubmissions University provides adult learners with accessible, reasonably priced, training and education on electronic submissions that are destined for and/or filed with the United States Food and Drug Administration (FDA). eSubmissions University is exclusively dedicated to providing electronic submissions education for:
Employees of small businesses, sole proprietors or consultants,
Employees of a university, college, or not-for-profit research center/institution,
Employees of contract research organizations serving small businesses, and/or
Any person/company subject to the FDA's electronic submission requirements.
The goal of eSubmissions University, is to provide reasonably priced, high-quality training and education to meet FDA requirements for electronic submissions.
Since 2000 the electronic submission paradigm has been steadily adopted by many groups of FDA filers, including large pharmaceutical companies, but other groups with limited resources and scant electronic capabilities have been slow adopters or avoiders in the journey to an all-electronic submission paradigm. For this latter group, there is no easy path or conduit to the training and education required for their movement away from paper-based filings to the electronic submission paradigm.
eSubmissions University is one answer to this need.
Given the global nature of health products and health product companies, future educational efforts may also focus on electronic submissions formats and requirements for countries outside the United States.