Sentence examples for authorisation studies from inspiring English sources
Clinical study reports of marketing authorisation studies are also commonly used (6/10 responses), while study protocols are required and included in Germany and France.
Health-Related Quality of Life (HRQoL) is among the most used variables in Health Outcomes Research HORR) in the academic field, as well as in clinical trials and post-authorisation studies.
Screening to detect signals in the general population and in observational cohorts; Controlled trials for more targeted assessments; Other PRO-AE-based approaches in post-authorisation studies, for instance, the proactive follow-up of patients after occurrence of an AE of special interest (which may include a medical confirmation of the detected events through the event-treating physician).
In a post-authorisation study of the AS03 adjuvanted H1N1 vaccine in the United Kingdom, pregnancy outcomes from 265 vaccinated pregnant women were reported 12; the prevalence of spontaneous abortions and stillbirths was comparable to expected rates.
Post-authorisation safety studies (PASS) of vaccines assess or quantify the risk of adverse events following immunisation that were not identified or could not be estimated pre-licensure.
A post-authorisation safety study was carried out as part of the EU Risk Management Plan to examine the long-term (up to 12 months) use of quetiapine XL as prescribed in general practice in England.
Classification and authorisations: The study protocol was submitted to the Spanish Agency of Drugs and Health Products (the competent authority) and classified as a 'postauthorisation study with design other than prospective follow-up' requiring no further authorisations (SPM-ACO-2014 01; 12 March 2014).
Data were assessed from an ongoing, multinational, prospective, observational post-authorisation safety study being conducted to evaluate post-injection delirium/sedation syndrome (PDSS), an adverse reaction that can occur following injection of olanzapine LAI.
8 In conclusion, we observed authorisation bias in studies requiring informed consent for use of data from medical records.
The outcome was defined as a successful EU marketing authorisation within the study period (April 2000-October 2006).
