Practical considerations for creating a strategic and proactive clinical safety and pharmacovigilance organization for the future.

ABSTRACT:

Background

In 2012, Patient Safety (PS) in AstraZeneca was facing a situation with multiple challenges, scientifically and structurally.

Objective

To meet these and support AstraZeneca's ambition to return to growth after years of patent expiry, we undertook a project to fundamentally revisit ways of working to create an organisation set up to provide strategic safety in support of drug project decision-making.

Method

In this paper, we describe the challenges we faced, the project to deliver changes to respond to them, and the methodology used. The project had two main components: creating a new operating model and simplifying the procedural framework.

Results

It was delivered in a focused effort by internal PS resources with cross-functional input. The framewo

SUBMITTER: Nord M 

PROVIDER: S-EPMC8461661 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature