Introduction An example of patient’s own experience of being used as an interface between sponsors and participants of clinical trials. Taking place both in rare diseases with EURORDIS and...
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...
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...
Introduction A case report on patients recruited by Janssen R&D in a program constructed for the EATG members. Afterwards, the course was handed over for further capacity building within...
Traditionally, health data has been generated by documenting patients’ records (i.e. clinicians’ notes, lab results, prescriptions etc.) in a paper-based system. However, this system has several challenges such as...
Patient advocates can be involved in early clinical development through partnerships and working relationships with regulatory authorities, ethics committees, investigators, and industry. They can provide input and play an...
Special considerations must be taken into account in the development of paediatric medicine, including in terms of research and trial design and ethical concerns.
1. Introduction Translational medicine also referred to as translational science or translational research, is defined[¹] as an area of biomedical research that aims to improve human health and longevity...
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