There are several new research areas driving personalised medicine forward, such as molecular genetics, epigenetics, pharmacogenetics, and the development of biomarkers and biomedicines.
Participants of clinical trials have rights that are protected by law, and they also have specific responsibilities. Participants' organisations have close relationships with the patients in a clinical trial...
After Phase III of clinical studies, all the information on a medicin is collected and organised in a pre-determiend format (a dossier), which is then submitted to the regulatory...
When women of childbearing potential are included in clinical trials, safety precautions must be taken in order to avoid the unintentional exposure of an embryo or fetus to the...
Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one...
The way patients are involved in an HTA body depends on the political and cultural context. Patient involvement in HTA should be developed as the result of a partnership...
Early Clinical Development refers generally to the first studies of a medicine in humans – typically known as Phase I and Phase II trials. Studies in early clinical development...
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...
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...
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