The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time points post-authorization.
Latest Glossary Definitions
A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the marketing authorisation holder (MAH) with respect to one or more authorized medicinal products.
Protocol assistance is the special form of scientific advice available for companies developing designated orphan medicines for rare diseases.
Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market.
Scientific advice is the provision of advice to a company by the European Medicines Agency on the appropriate tests and studies required in the development of a medicine or on the quality of a medicine.
Quality by design (QbD) is an approach that aims to ensure the quality of medicines by employing risk management, experimental and statistical methodology in the design, development and manufacturing of medicines.
Signal detection process is a set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, literature information or other data sources, there are new risks causally associated wit
In order for health authorities to monitor the safety of investigational drugs, sponsors of clinical trials are required to submit safety reports of certain adverse events that occur during their clinical trials.
Adverse event (AE) means any untoward medical occurrence associated with the use of a drug or pharmaceutical product in humans, whether or not considered drug related.
A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products including the assessment of the effectiveness of those activities and interventions