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 term 'personalised medicine' includes both stratification and personalisation, which are often incorrectly used as synonyms. However, the two are different, as explained further below.
Participants of clinical trials have rights that are protected by law, and they also have specific responsibilities. Participants' organisations have close relationships with the patients in a clinical trial...
After Phase III of clinical studies, all the information on a medicin is collected and organised in a pre-determiend format (a dossier), which is then submitted to the regulatory...
When women of childbearing potential are included in clinical trials, safety precautions must be taken in order to avoid the unintentional exposure of an embryo or fetus to the...
Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one...
Phase I trials are usually the first studies of a medicine conducted in humans – known as ‘first-in-human’ (also known as first-in-man) trials. They are typically human pharmacology studiest,...
