Per Protocol AnalysisAn analysis that is restricted to the participants who fulfil the protocol in terms of the eligibility, interventions, and outcome assessment. This analysis restricts the comparison of the treatments outcomes to the participants who adhered perfectly to the clinical trial instructions as(...)
Performance-linked access systemA performance-linked access system is a system used to minimise known safety risks of a medicine, once it is on the market. These systems guide prescribing, dispensing, and use of the medicine.
They are put in place when products have significant or unique benefits in a particular patient(...)
PLASA performance-linked access system is a system used to minimise known safety risks of a medicine, once it is on the market. These systems guide prescribing, dispensing, and use of the medicine.
They are put in place when products have significant or unique benefits in a particular patient(...)
Period of ExclusivityA period of exclusivity refers to a time after a medicine is authorised during which no other similar medicines with the same indications (intended uses) may be authorised. This protects the medicine from competition during the period of exclusivity. There can be several separate market(...)
Periodic Benefit Risk Evaluation ReportA Periodic Benefit Risk Evaluation Report is a format of safety report described by the ICH-E2C(R2) guideline which is used as a basis for the EU Periodic Safety Update Report (PSUR). The report is produced by the marketing authorisation holder (the individual or business that is granted(...)
PBRERA Periodic Benefit Risk Evaluation Report is a format of safety report described by the ICH-E2C(R2) guideline which is used as a basis for the EU Periodic Safety Update Report (PSUR). The report is produced by the marketing authorisation holder (the individual or business that is granted(...)
Periodic Safety Update ReportA Periodic Safety Update Report (PSUR) is EU terminology for a Periodic Benefit Risk Evaluation Report (PBRER). It is produced by the marketing authorisation holder (the individual or business that is granted authorisation to market a medicine) at defined time points after a medicine has been(...)
