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...
The processes of patient involvement in industry medicines research and development have evolved, but the evolution of frameworks, mechanisms, metrics and processes happens individually without much alignment and sharing.
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...
A recording of the EUPATI webinar entitled 'Creating Trainings with the EUPATI Toolbox'. In the first part of the webinar John Lenehan will present the usage statistics of the...
To obtain clinical trial approval, a Clinical Trial Application must be submitted to regulatory bodies and a Research Ethics Committee who review the protocol and gives a positive or...
‘Within-trial decisions’ are decisions made once a clinical trial has already begun, for instance if an unexpected problem comes to light. This article looks at two specific kinds of...
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...
Medicine adherence (also known as ‘patient adherence’ or ‘compliance’) is how well patients follow doctors’ instructions about the timing, frequency, and dosage when taking a medicine.
During clinical development the manufacturing and distribution facilities available may not be suitable for a trial medicine (investigational medicinal product (IMP)), however, IMPs must be manufactured, stored and distributed...
Safety communication is put in place to communicate adverse reactions or any safety findings to regulators, healthcare providers and patients. Safety communications are provided by marketing authorisation holders and...
