借助信息技术工具在临床及其他场景中支持主动药物警戒：监管与管理方面

Supporting Active Pharmacovigilance via IT Tools in the Clinical Setting and Beyond: Regulatory and Management Aspects.

作者信息

Natsiavas Pantelis, Gavriilidis George I, Linardaki Zacharoula, Kolangi Georgia, Gkaliagkousi Evgenia, Zamboulis Chrysanthos, Jaulent Marie-Christine

机构信息

Institute of Applied Biosciences, Centre for Research & Technology Hellas, Thermi, Thessaloniki, Greece.

Sorbonne Université, INSERM, Univ Paris 13, Laboratoire d'Informatique Médicale et d'Ingénierie des Connaissances pour la e-Santé, LIMICS, F-75006 Paris, France.

出版信息

Stud Health Technol Inform. 2020 Jun 26;272:342-345. doi: 10.3233/SHTI200565.

DOI:10.3233/SHTI200565

PMID:32604672

Abstract

Information Technology (IT) could have a prominent role towards the "Active Pharmacovigilance" (AP) paradigm by facilitating the analysis of potential Adverse Drug Reactions (ADRs). PVClinical project aims to build an IT platform enabling the investigation of potential ADRs in the clinical environment and beyond. In this paper, we outline the respective EU regulatory framework and the related Business Processes (BPs), elaborated based on input from clinicians and PV experts as part of the project's "user requirements analysis" phase, highlighting their potential pivotal role in the design of IT tools aiming to support AP.

摘要

信息技术（IT）通过促进对潜在药物不良反应（ADR）的分析，在“主动药物警戒”（AP）范式中可以发挥重要作用。PVClinical项目旨在构建一个IT平台，以便在临床环境及其他场景中调查潜在的ADR。在本文中，我们概述了相应的欧盟监管框架和相关业务流程（BP），这些是在项目“用户需求分析”阶段基于临床医生和药物警戒专家的意见精心制定的，强调了它们在旨在支持主动药物警戒的IT工具设计中可能发挥的关键作用。