Ljubljana
Advanced
This workshop is aimed at experienced medical writers who already are accomplished in the ‘paper’ world and desire to ease their (and their employer’s) transition to electronic regulatory submissions.
Objective
The purpose of this workshop is to introduce medical writers to the elements of electronic regulatory submissions (e-Subs), including the historical context. Upon completion of the workshop package, participants should be able to understand the basic requirements of an electronic submission and to aid anticipatory planning within their organisation.
Content
The FDA and EU are moving rapidly into the era of electronic regulatory submissions. This workshop will review the features of an e-Sub as well as the technology requirements. Strategies will be discussed for incorporating e-Subs into the design of research programs, building databases, analysing and interpreting data, preparing reports, and providing quality assurance. This workshop will explore these issues and provide guidance for preparing an e-Sub.
Pre-workshop assignment: 02:00 hours
Post-workshop assignment: 03:00 hours