Medical devices are articles or instruments used in disease prevention, diagnosis, or treatment. Medical devices range in form and function, ranging for instance from inhalers to pacemakers to magnetic...
During the non-clinical safety testing step of the medicines discovery and development process, molecules undergo safety testing in animal subjects in order to determine whether or not they are...
Special considerations are necessary when prescribing medicines in special populations, such as children, the elderly, pregnant and breastfeeding women, and patients with renal (kidney) or hepatic (liver) impairment.
The power of the patient voice is phenomenal, and inspires, motivates, informs, challenges and advises us during our awareness seminars. It may sound simple – share your experience and...
The Investigator's Brochure is a compilation of non-clinical and clinical data relevant to the study of the medicine in humans – it is the single most comprehensive document summarising...
A Data Safety Monitoring Board (DSMB) is a group of independent individuals, external to the trial, who are experts in relevant areas. They review the accumulated data from clinical...
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...
Code of Conduct for all stakeholders involved in patient engagement activities within medicines development. Background/Rationale There is no European or international legislation defining the rules for patient engagement in...
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