In the last decades, the evolution of new technologies contributed to the development and implementation of the new regulatory framework on which Medical Devices Regulation (MDR) and In Vitro...
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,...
Note: This webinar took place on 26 September 2017. You can find a video recording and the presentations used during the webinar below. Webinar introduction Increasingly, patient advocates take part in...
A very important result from the EUPATI project was the development, broad consultation and final release of guidances on the best approach to interaction of patients with pharmaceutical industry-led...
What is compassionate use? The term ‘compassionate use’ refers to special programmes set up to make unauthorised medicines available to patients. In particular, this may be a way of...
A falsified medicine is a fake that passes itself off as a real, authorised medicine but contains poor quality or falsified ingredients, no ingredients or in the wrong dose...
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...
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...
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...
