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...
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 medicines development process' ultimate goal is an approval for marketing the new medicinal product – a Marketing Authorisation. This should be an integral part of all steps throughout...
Introduction A collaboration of the Patient Consumer Group [part of National Research Institute for Health Research (NIHR), Clinical Research Network] with the pharmaceutical company Eli Lilly. Where in the...
Introduction A case report on Phase I patient involvement into study design through interviews where they share their views on the disease and the cutaneous symptoms. The information that...
HTA is a multidisciplinary process that examines the information about medical, cost-effectiveness, social, political, legal and ethical considerations of the application of a health technology – usually a medicine,...
Introduction This is a collaboration between Bristol-Myers Squibb (BMS) with FUNDHEPA (patient organisation) to give more patients the opportunity to receive an innovative treatment for Hepatitis C through the...
Digital health technologies (DHT) can be deployed over a broad range of use in healthcare. This entails different approaches in their regulation and the assessment of their benefits, risks,...
