Introduction A collaboration of the CML Advocates Network / Leukaemia Patient Advocates Foundation with a major pharmaceutical company regarding the use of a medicine in Phase III trials (adult...
Patient engagement in medicines development: Recommendations on how to find the right match for the right patient engagement activity. Background/Rationale for the document During the analysis of existing practices...
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...
Risk management is important in medicines development and pharmacovigilance in order to avoid crisis situations and harmful consequences. There are various kinds of risk; risk management strategies must assess...
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.
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,...