Rechallenge information is not required to fulfil this definition 3 Possible A clinical event, including laboratory test abnormality, with a reasonable time sequence to administrations of the drug, but which could also be explained by concurrent disease or other drugs or chemicals. Information on drug...
Our purpose should be to establish a PV data analytics process designed to leverage big data and the benefits of using such data across the value chain to build synergy between traditional (including regulatory obligations) analytics and big data analytics to provide faster and better insights to t...
The definition of a herbal product as a food or medicine may therefore have considerable impact for pharmacovigilance. 2.2. Nomenclature and what was used Adverse reaction reports, whether submitted to regulatory authorities or published in the medical literature, are meaningless if the medicinal herb(...
for the company to set up a pharmacovigilance system, a “qualified person” to oversee the pharmacovigilance activities within the company is still needed. The definition of “qualified person” without the context of EU/EEA requirement can be discussed. ...
and enables coding of pharmacovigilance reports using medical terms of the second controlled medical, adverse-event terminology based on a formal definition provided using medical terms of the first controlled medical terminology, wherein the second controlled medical, adverse-event terminology is a Medica...
1235/2010), has radically changed the definition of "adverse reaction": now, medical professionals are de facto obliged to report all observations of undesirable events correlated, with high probability, with the use of a drug. In the new EU Directive, even lack of efficacy is con- sidered ...
According to the WHO, healthcare professionals "maintain health in humans through the application of the principles and procedures of evidence-based med- icine and caring" (WHO Education Guidelines 2016). In line with the WHO's definition, we are including the following groups under the general...
Regarding seriousness, ADR reports were characterized based on the definition of Good Pharmacovigilance Practices, Module VI [20], where a serious ADR is any reaction that causes death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or ...
However, despite the definitional differences between an ADR and an adverse event, for regulatory reporting purposes, if an event is spontaneously reported, even if the relationship is unknown or unstated by the healthcare professional or consumer as the primary source, it meets the definition of ...
The conditions for using the capture-recapture method were checked: i/all cases are real cases and the case definition must therefore be rigorously the same from each source, ii/homogeneity of capture between all sources must be equal, iii/the population studied must be a closed population, iv...