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Consulta pública a decorrer para Projeto de Regulamento de Execução sobre consultas científicas conjuntas de medicamentos
Foi publicada, na área Consultas Públicas do site do INFARMED, I.P., a abertura de nova consulta pública no âmbito da implementação do Regulamento do Parlamento Europeu e do Conselho da União Europeia relativo à Avaliação de Tecnologias de Saúde (ATS), nomeadamente...
EUDAMED user guide Guidelines on Data Exchange with EUDAMED
The purpose of this document is to help Competent Authorities, Notified Bodies, as well as all Economical Operators (Manufacturers, Authorised Representatives, Importers, and System/Procedure Pack Producers) in assessing the most cost-efficient solution for their...
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
This document provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical...
Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle
The utilisation of artificial intelligence (AI) is an important part of the digital transformation. Such systems are often developed through the process of machine learning (ML) where models are trained from data, with or without human input. However, as these models...
