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.
Latest Glossary Definitions
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
Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market.
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.
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.
A Safety Data Exchange Agreement is a legal written contract which ensures that all safety data regarding a medicinal product makes its way quickly and reliably back to the marketing authorisation holder so that they may fulfil their legal obligations
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
Protocol assistance is the special form of scientific advice available for companies developing designated orphan medicines for rare diseases.
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 TPP is a format for a summary of a drug development program described in terms of labeling concepts.