Possibly the highest level of medicine-like health claim that can be made on a non-drug product. It describes the propensity for the product or dietary ingredient to aid in the reduction of the risk factors associated with particular diseases.
These are specially formulated foods that provide partial or complete nutrient requirements for post-operative convalescing patients or other nutritionally vulnerable subjects with specific medically determined dietary requirements, which may not be adequately met by consuming normal diets.
Data collected in the frame of a clinical trial must be recorded in order to ensure that the protocol is complied with and as a basis for the analysis of the study results.
Investigators need to be provided with information about the investigational medicinal product (IMP) data, in order to facilitate their understanding of the rationale for, and their compliance with, key features of a clinical trial protocol.
Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients.
An Individual Case Study Report is an adverse event report for an individual patient.
The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time points post-authorization.
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.
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
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