The development of Medical Devices should involve patients and the public throughout each stage: innovation, assessment, implementation and evaluation.This is essential in order to ensure that Medical Devices address...
”Enhance your reading experience by turning on the subtitles of the accompanying video.” Transcript [What training does a patient need in order to participate in a HTA process?] Jan...
This article explores patient involvement in scientific regulatory committees in the EU, specifically in the activities of the European Medicines Association (EMA).
Phase III clinical studies, or confirmatory studies, are the final confirmation of the safety and efficacy of a medicine before it can be launched on the market. Phase III...
Early Clinical Development refers generally to the first studies of a medicine in humans – typically known as Phase I and Phase II trials. Studies in early clinical development...
Transcription I’m Gilli Spurrier-Bernard. I am a patient advocate because my husband is a stage 4 melanoma patient. As a patient advocate I initiated the Melanome France group...
The medicines development process' ultimate goal is an approval for marketing the new medicinal product – a Marketing Authorisation. This should be an integral part of all steps throughout...
