HTA is a multidisciplinary process that examines the information about medical, cost-effectiveness, social, political, legal and ethical considerations of the application of a health technology – usually a medicine,...
‘Within-trial decisions’ are decisions made once a clinical trial has already begun, for instance if an unexpected problem comes to light. This article looks at two specific kinds of...
A very important result from the EUPATI project was the development, broad consultation and final release of guidances on the best approach to interaction of patients with pharmaceutical industry-led...
Patient engagement in medicines development: Recommendations on how to find the right match for the right patient engagement activity. Background/Rationale for the document During the analysis of existing practices...
Introduction A collaboration of Genzyme, International Pompe Association (IPA); UK, Dutch, and US Pompe patient organisations, Erasmus Medical Center and Duke University to establish appropriate measures to ensure the...
Introduction A case report on the inclusion of a patient expert on a pharmaceutical company’s external Bioethics Advisory Panel. The patient expert was proposed to the existing panel so...
Transcription Well, my name is Diego, Diego Villalón, I had lymphoma when I was 23 and since then I’ve been involved in patient… In different patients organisations. Two...
Transcription My name is Tamás Bereczky, I come from Budapest, Hungary. I have been working with EUPATI as a patient representative or the representative of a patient organisation,...
Introduction RWD and RWE are defined by the European Medicines Agency (EMA)[2] as a regulatory authority as such: RWD: “routinely collected data relating to a patient’s health status or...
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