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...
Introduction A Polish breast cancer patient’s organisation contacted Novartis for information on conducted clinical trials with the aim to publish the information in their site. Investigators were informed and...
Published and available for citation: Hunter A, Facey K, Thomas V, Haerry D, Warner K, Klingmann I, May M and See W (2018) EUPATI Guidance for Patient Involvement in...
Off-label use of a medicine is the use of an authorised medicine by a healthcare professional to treat a patient in a way not covered by the Marketing Authorisation...
Information on medicinal products is provided to patients and healthcare providers in different, carefully regulated ways – including package labelling, package leaflets, and the Summary of Product Characteristics.
The Investigator's Brochure is a compilation of non-clinical and clinical data relevant to the study of the medicine in humans – it is the single most comprehensive document summarising...
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...
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.
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.OkPrivacy policy
