Risk factors are those factors linked to poor health, disability, disease, or death. Generally, risk factors can be classified as behavioural, physiological, demographic, environmental, or genetic. Reducing exposure to...
Phase II clinical studies, or proof of concept studies, begin to test the effect of a medicine on the target disease in humans. These studies are usually run as...
Developing medicines for children is important, but requires special measures to be taken during clinical development in order to shield children from undue risk.
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...
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