Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.

Latest Glossary Definitions

Pharmacovigilance System Master File (PSMF)

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 (PA)

Protocol assistance is the special form of scientific advice available for companies developing designated orphan medicines for rare diseases.

Scientific Advice (SA)

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)

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

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

Suspected Unexpected Serious Adverse Reaction (SUSAR)

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.

Serious Adverse Event (SAE)

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.

Risk Management Plan (RMP)

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

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