In the process of conceiving a pharmacovigilance plan, as proposed in the International
Conference on Harmonisation E2E guideline, the challenge will be how to address possible …

The problems relating to the use of medicines are manifold. They may differ in
pharmacological, pathological, epidemiological and legal respects, and may have different …

A new approach is proposed for assessing causality in pharmacovigilance. The Dx3
approach is designed to qualitatively evaluate three types of dispositions when assessing …

A tripartite group, entitled «CRI»(for Cercle de réflexion sur l'imputabilité), involving French
pharmacovigilance staff from the French network of the Regional centers of …

Background An updated probabilistic causality assessment method and the Liverpool
algorithm presented as an improved version of the Naranjo algorithm, one of the most used …

Only few applications are currently dealing with personalized adverse drug reactions
(ADRs) prediction in case of polypharmacy. The study aimed to develop a patient-tailored …

The methods for causality assessment of adverse drug reactions were developed in the
1970s and 1980s, alongside the development of pharmacovigilance. The French method is …

About forty years ago pharmacovigilance started as a formal public health practice with the
setting up of spontaneous reporting schemes. This can be recognised as the first generation …

Marketing authorisations for medicines need to be based on the universal criteria quality,
safety and efficacy, whilst taking into account local public health needs. With view to using …

Researchers, regulatory agencies, and the pharmaceutical industry are moving towards
precision pharmacovigilance as a comprehensive framework for drug safety assessment, at …