Complimentary Webinar: How To Work With Study Tagging Files For US FDA Submissions

Study Tagging Files (STF) are a requirement for US FDA submissions. They help to identify all of the files associated with a study. The required information includes items like the document title, subject matter, relationship to other documents, revision, the document's location, and information on the submission.
The eCTD backbone files contain only parts of those information items. Therefore additional information has to be provided in the STF.

In this webinar focussed on STF, Susan Paisley will highlight the two configuration setting options for creating STFs. She will explain how to put together the study with the correct file tags, talk about the 
new study validation criteria and show how the study structure can be customized. Following the theoretical part, Dominique Hetrick will demo, how this is handeled in EXTEDO's eCTDmanager.

Agenda

  • EXTEDO corporate intro
  • Cover the two configuration setting options for creating STFs
  • How to put together the study with the correct file tags
  • Touch on the new study validation criteria related to studies
  • Customizing the structure
  • Q&A session

Time and Date

Thursday, 07 October 2021 | 08:00 am PDT (Los Angeles, Seattle) | 11:00 am EDT (NY, Philadelphia) | 04:00 pm BST (London, Lisbon) | 05:00 pm CEST (Madrid, Berlin)