Category: PV training material

Haemovigilance: A set of surveillance procedures covering the whole transfusion chain (from the collection of blood and its components to the follow-up of recipients), intended to collect and assess information on unexpected or undesirable effects resulting from the use of labile blood products, and to prevent their occurrence or recurrence  Adverse event: An unintended and…

Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL). Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death…

Simvastatin therapy may be associated with rare cases of interstitial lung disease. This is suggested by a retrospective study conducted on 34 patients with suspected pulmonary toxicity from simvastatin, which investigated the role of pharmacogenetic factors and concomitant therapies in the development of this syndrome.In 70.5% of cases, pulmonary toxicity was due to the use…

A computerized system can include hardware, software, its peripherals, interfaces, equipment, users, and operating procedures. Today, in the health products industry that encompasses pharmaceuticals, biologics, vaccines, biotechnology, natural health products, medical devices, cosmetics and allied industries, software and hardware components are used for the purposes of data processing, data storage, and process control. Computer system…

The Pharmacovigilance System Master File (PSMF) is a document, designed to summarize the pharmacovigilance (PV) system of the marketing authorization holder (MAH). This document is named differently in many countries, namely, PvMF in India and in the EU, it is known as PSMF.  Objective of PSMF: Describe the pharmacovigilance (PV) system Support/document PV system’s compliance…

Most of the information about the safety of a drug prior to marketing comes from clinical trials. Adverse event reports from investigators are therefore critically important, given that it is the investigators who observe subjects responses to an investigational drug.  The investigator must immediately report to the sponsor any SAEs, regardless of whether the investigator…

An individual case safety report of one or more adverse events that must be submitted within a specified amount of time due to the severity of events, is Expedited reporting Worldwide regulatory authorities require expedited reporting of individual cases received by drug companies that meet specific criteria like validity, seriousness, expectedness of events and relation…

The majority of medicinal products or chemical substances administered to a pregnant woman could have effects on the foetus either before the placenta is fully developed or subsequently, if they can cross the placenta to at least some extent. Substances used for therapeutic purposes in the mother have the potential to reach the foetus with…

Adverse event is any untoward change to medical condition affecting a patient receiving a medicine, although it is not known whether a causal relationship to treatment with this medicine exists.Adverse event can therefore be: any adverse or unintended sign (for example, an abnormal laboratory finding) symptom disease temporarily associated with the use of a medicinal product, whether ornot a…