Understanding Publishing Flashcards
1
Q
Regulatory Submissions is a group under which function?
A
PDR-Operations
2
Q
What is considered the blueprint for building the dossier?
A
eCTD Tracking Sheet
3
Q
The Dossier Finalization Period occurs during the last ___ business days leading up to the Filing date.
A
10
4
Q
During final team review, who are the main reviewers?
A
Program Management leads
5
Q
Which of the following is a U.S.-only activity?
A
Rolling Submissions
