Medicines regulation is the basis for ensuring that only medicines of a high quality are marketed. In Europe, the European Commission proposes high-level legislation in the form of regulations...
During clinical development the manufacturing and distribution facilities available may not be suitable for a trial medicine (investigational medicinal product (IMP)), however, IMPs must be manufactured, stored and distributed...
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...
Working with Community Advisory Boards: Guidance and tools for patient communities and pharmaceutical companies Background/Rationale for the document Community Advisory Boards (CABs) can improve research by providing direct and...
Introduction An example of patients involved through patients and patient organisations providing inputinto a Cushing’s disease clinical trial design. The consultation took place between Novartisand nurses from different teams (USA, Canada,...
Introduction Patients were asked by GlaxoSmithKline staff members to review a draft plain language summary from a completed Phase III study. The patients provided valuable feedback about the wording,...
Transcription I’m Dominique Hamerlijnck. I’m one of the patient advocates from the Dutch Lung Foundation. We do quite a lot of different projects, and usually it goes two...
Transcription I am a Victoria Fonsou, from Greece. I am a breast cancer patient and also a caregiver of my father, who has just been diagnosed with colon...
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