The “Storyline Document”, A New Document Format for the Use in Pre-submission Meetings

Time

Tue, Jun 26 11:00AM
T 04

Title

The “Storyline Document”, A New Document Format for the Use in Pre-submission Meetings

Abstract Summary

This conceptual paper introduces the "story line document" as new format for the use in pre-submission meetings with regulatory agencies. The story line document summarizes the background information for the clinical part of pre-NDA meetings in a succinct way. It comprises sections on the drug profile, previous interactions with FDA and the clinical development programme, as well as definitions of endpoints, study groupings, and subgroups.

Poster Presenter

Sybille M Eibert
Senior Medical Writer / Teamleader,
Boehringer Ingelheimpharma Gmbh & Co. KG
Germany

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