Article

Implementation of a Centralized Pharmacovigilance System in Multi-Country European Clinical Trials: Points to Consider for Academic Sponsors and Lessons Learnt from EU-Response and Connect4Children Consortia

2022-10-17

Abstract excerpt

<h4>Setting: </h4> -up a high quality and efficient pharmacovigilance (PV) system in multi-country clinical trials can be more challenging for academic sponsors than for industrials. Generating high-quality safety data, compliant with legal and regulatory standards such as European or World Health Organization (WHO), places special requirements on the PV system. The scenario becomes more complicated when dealing w...

Topics

Open a Topic to create a Post that cites this publication.

Identifiers and source

Literature Corpus work: 47c4ead7-52f8-53a7-8b78-7843421a3789
DOI: 10.22541/au.166602424.41788458/v1

Open publication

Related research

Semantic proximity does not establish scientific evidence.

Click a neighbor to travelStep 1 · 12 closest

Implementation of a Centralized Pharmacovigilance System in Multi-Country European Clinical Trials: Points to Consider for Academic Sponsors and Lessons Learnt from EU-Response and Connect4Children ConsortiaDOI 10.22541/au.166602424.41788458/v1Read

Pharmacovigilance in China: A reviewSemantic proximity Read

Ethical and Procedural Issues For Applying Researcher-Driven Multi-National Paediatric Clinical Trials in and Outside The European Union: The Challenging Experience of The DEEP ProjectSemantic proximity Read

A disproportionate analysis of novel oral anticoagulants in the overall and pediatric populations: a pharmacovigilance study based on FDA Adverse Event Reporting System databaseSemantic proximity Read

Pharmacovigilance in Low and Middle-Income Countries: A review with particular focus on AfricaSemantic proximity Read

The Adverse Event Atlas and Signal Consensus Index: A Multi-Source Pharmacovigilance PlatformSemantic proximity Read

Rare Diseases Clinical Trials Toolbox - Public resources and main considerations to set up a clinical trial on medicinal products for humans in EuropeSemantic proximity Read

Data analysis planning and reporting for confirmatory multi-lab preclinical trialsSemantic proximity Read

Developing Generic Templates to Shape the Future for Conducting Integrated Research Platform TrialsSemantic proximity Read

Real-world pharmacovigilance study of voclosporin based on FAERS and VigiBaseSemantic proximity Read

Call to Action: Harmonisation of Pharmacovigilance Regulations for Post-marketing Pregnancy and Breastfeeding Safety StudiesSemantic proximity Read

Characteristics and data reporting of rare disease clinical trials: Getting better but still room for improvementSemantic proximity Read