Complimentary Webinar: US FDA Grouped Submissions

The US FDA allows applicants to submit a common change, for many submissions, within one main submission. Submission Grouping has high business value, saving applicants time and effort. However, experience shows that the compilation and control carry risks of errors.

During the webinar, Susan Paisley (EXTEDO) will talk about the priciple and limitations of use of submission grouping. She will give you an overview about lifecycle maintenance as well as what to consider from a business and regulatory point of view.
Following the theoretical part, Dominique Hetrick (EXTEDO) will give you a live demonstration how grouped submissions are managed within eCTDmanager. At the end of the webinar, the speakers will answer your questions in the Q&A session.

Agenda

  • EXTEDO corporate intro
  • Learn about the principle of grouped submissions
  • Limitations of submission grouping 
  • Lifecycle maintenance of grouped submissions
  • Lifecycle of regular submissions
  • Importing grouped submissions
  • Hints and warnings
  • eCTDmanager live demonstration
  • Q&A session

Time and Date

Thursday, 04 March 2021, 10:00am EST (New York) | 03:00pm GMT (London) | 04:00pm CET (Berlin)