A Paediatric Investigation Plan (PIP) must be submitted in order to support a medicine's authorisation for use in children. The PIP undergoes a review process and ensures that paediatric...
In the current Clinical Trials Directive, the definition of conditions for inclusion of vulnerable populations is limited to clinical trials with minors and incapacitated adults who are not able...
The starter kits provide you with links to relevant background reading in the toolbox and associated PowerPoint slide decks and media in order to prepare a single or multi-day...
The starter kits provide you with links to relevant background reading in the toolbox and associated PowerPoint slide decks and media in order to prepare a single or multi-day...
Enhancement of the EUPATI industry guidance Background/Rationale for the documents During the PARADIGM project further expansion of specific sections of the EUPATI Guidance for Patient Involvement in Medicines Research...
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...
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