Introduction A case report on Phase II patient involvement into Proof of Concept study design, to improve probability of success generating patient-relevant data and meeting current regulatory needs. Where...
Introduction Partners from Ethic Committees (National Commission of Ethic Committees – CNCP), patient associations, and investigating centres worked in a writer’s guide of five recommendations and six rules for...
Introduction Novo-Nordisk, a pharmaceutical company, does user research with patients to enhance understanding of patients and to develop products that meet users’ needs. Where in the process? – Phase...
Transcription My name is Pauline Kitchiner, and I work at GSK’s Clinical Unit in Cambridge. Which is a purpose built clinical unit to conduct phase one or phase...
In the last decades, the evolution of new technologies contributed to the development and implementation of the new regulatory framework on which Medical Devices Regulation (MDR) and In...
Gene therapy is a way of restoring the function in cells where genes are missing or not working properly. It is a highly experimental technique, but has shown promise...
Pharmacology is the study of how a medicine works, how the body responds to it, and the changes that occur over time. There are two key areas of pharmacology:...
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