Work

EMA – Draft of Data Quality Framework for EU medicines regulation application to real-world data

Year: 2024

Type: other

Abstract: The EMA is currently carrying out a public consultation on the Data quality framework for medicines regulation chapter dedicated to real-world data . The chapter under consultation provides guidance on how to assess the quality of real-world data in the evaluation of medicines. It aims to enhance the use of real-world data in regulatory decisions. This document describes the Real-World Data (RWD) specific recommendations as derived from the Data Quality Framework (DQF) for EU Medic...

Source: Industrias Culturais (Universidade de Coimbra)

DOI: 10.58079/12wce

Author: Vroby

Language: English

Topic: Pharmacovigilance and Adverse Drug Reactions

Subfield: Toxicology

Field: Pharmacology, Toxicology and Pharmaceutics

Domain: Life Sciences

Open Access status: green

OpenAlex ID: W6899150401

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