2 results match your criteria: "Patient Safety Centre of Excellence[Affiliation]"
Practical considerations for creating a strategic and proactive clinical safety and pharmacovigilance organization for the future.
Int J Risk Saf Med
October 2021
Global Patient Safety Oncology Therapy Area, Chief Medical Office, R&D, AstraZeneca, Gaithersburg, MD, USA.
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.
Investigating Overlap in Signals from EVDAS, FAERS, and VigiBase.
Drug Saf
April 2020
Safety Surveillance Data and Analytics, Patient Safety Centre of Excellence, Chief Medical Officer Organisation, AstraZeneca, Cambridge, UK.
Introduction: The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and VigiBase are two established databases for safety monitoring of medicinal products, recently complemented with the EudraVigilance Data Analysis System (EVDAS).
Objective: Signals of disproportionate reporting (SDRs) can characterize the reporting profile of a drug, accounting for the distribution of all drugs and all events in the database. This study aims to quantify the redundancy among the three databases when characterized by two disproportionality-based analyses (DPA).