Storyboarding as best practice for marketing applications

Bowers, Alison and Young-Sil, Yim 2021. Storyboarding as best practice for marketing applications. Regulatory Rapporteur 18 (7/8) , pp. 18-22.

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Abstract

This article describes the concept of storyboarding and best practices for preparing and running a ‘key messages’ meeting (known as a storyboarding meeting) to support an authoring and review team for a marketing authorisation application (MAA), new drug application (NDA), or biologics license application (BLA). These practices are based on the authors’ conduct of storyboarding meetings for six projects of varying sizes and scope, including large and small molecules across different therapeutic areas, completed during, or subsequent to, Phase III clinical trials. Storyboarding can prevent stressful and inefficient rework during dossier preparation while facilitating the timeliness and quality of the final application.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Pharmacy
Publisher:	The Organisation for Professionals in Regulatory Affairs (TOPRA)
ISSN:	1742-8955
Related URLs:	Organisation
Date of First Compliant Deposit:	21 October 2024
Date of Acceptance:	19 April 2021
Last Modified:	16 Jan 2025 14:45
URI:	https://orca.cardiff.ac.uk/id/eprint/173156

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