Medicines must balance efficacy and safety, benefits and risks. The efficacy and safety of a medicinal product are tested thoroughly during its development, and carefully monitored after the product...
Phase I clinical studies, or proof of mechanism studies, test the safety of a medicine in humans. Usually, these studies are carried out in healthy human volunteers.
Special considerations must be taken into account in the development of paediatric medicine, including in terms of research and trial design and ethical concerns.
GxP is an abbreviation for generic good practice, which refers to the series of laws, regulations, and guidance that govern various areas of the research, development, testing, manufacturing, and...
Participant adherence is an essential part of every clinical trial and means ‘the extent to which participants follow the instructions they have been given for participating in the clinical...
Note: This webinar took place on 5 July 2017. You can find a video recording and the presentations used during the webinar below. Webinar introduction A very important result from the...
Patient Engagement in Early Dialogues: Tools and resources for HTA bodies Background/Rationale Early Dialogues with regulators and health technology assessment (HTA) bodies are a well-established processes in which medicines...
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