Getting overwhelmed by the news is an everyday struggle for those wishing to stay in touch with the latest news. Our newsletter should make it easier for those interested in pharmacovigilance regulations, advancement in the relevant use of artificial intelligence, and personal growth. Approaching with care, the same as we provide PV services, we thoughtfully pick articles every month to keep you updated.
This document is the sixteenth annual report of the Pharmacovigilance Inspectors Working Group (PhV IWG). The PhV IWG was established by the European Medicines Agency (hereinafter “the Agency”) within the scope of Article 57(1)(i) of Regulation (EC) No 726/2004. Following a report on its first year of operation, the PhV IWG mandate was endorsed by the Heads of Medicines Agencies on 18-19 May 2009 and by the Agency’s Management Board on 1 October 2009, thereby formally establishing the PhV IWG.
The FDA Adverse Event Reporting System (FAERS) has received increased reporting of allergic/hypersensitivity type reactions following infusion of a specific lot of Immune Globulin Intravenous (IGIV) listed below. Reports included serious adverse events, some of which were considered severe, requiring treatment with epinephrine, steroids, and/or admission to the emergency room or hospital. Though hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products, the increased reporting of hypersensitivity reactions to this lot presents heightened safety risks for patients.
Streptococcus pneumoniae is a bacterial pathogen that causes life-threatening infections, including pneumonia and meningitis. These infections are commonly treated with antibiotics, but antibiotics are becoming less effective against S. pneumoniae over time due to changes in the pathogen that cause drug resistance. This phenomenon, called antimicrobial resistance, is resulting in significant healthcare costs and deaths around the world.
And much more...
This document is the sixteenth annual report of the Pharmacovigilance Inspectors Working Group (PhV IWG). The PhV IWG was established by the European Medicines Agency (hereinafter “the Agency”) within the scope of Article 57(1)(i) of Regulation (EC) No 726/2004. Following a report on its first year of operation, the PhV IWG mandate was endorsed by the Heads of Medicines Agencies on 18-19 May 2009 and by the Agency’s Management Board on 1 October 2009, thereby formally establishing the PhV IWG.
EMA’s Emergency Task Force (ETF) and the African Medicines Agency (AMA) have published a joint position paper to support the timely start of clinical trials for potential vaccines against Ebola disease caused by Bundibugyo virus (BDBV). The paper was developed following a scientific consultation with relevant experts, hosted by AMA, EMA and the World Health Organization (WHO) on 24 August 2026.
Policy 72: Policy on the handling of information from external persons on breaches related to the authorisation, supervision and maintenance of human and veterinary medicinal products or other EMA activities
Streptococcus pneumoniae is a bacterial pathogen that causes life-threatening infections, including pneumonia and meningitis. These infections are commonly treated with antibiotics, but antibiotics are becoming less effective against S. pneumoniae over time due to changes in the pathogen that cause drug resistance. This phenomenon, called antimicrobial resistance, is resulting in significant healthcare costs and deaths around the world.
Most companies are transforming for AI faster than their cultures can keep up.
The aim of this study was to evaluate the electronic health record-adverse event search method for identifying and reporting additional potential adverse drug reactions in electronic health records to strengthen routine signal detection.
The FDA Adverse Event Reporting System (FAERS) has received increased reporting of allergic/hypersensitivity type reactions following infusion of a specific lot of Immune Globulin Intravenous (IGIV) listed below. Reports included serious adverse events, some of which were considered severe, requiring treatment with epinephrine, steroids, and/or admission to the emergency room or hospital. Though hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products, the increased reporting of hypersensitivity reactions to this lot presents heightened safety risks for patients.
We aimed to assess advanced pharmacovigilance bias-mitigation approaches by evaluating ranitidine-associated cancer signals in the FDA Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) databases alongside a systematic review of comparative safety studies.
Direct oral anticoagulants (DOACs) are widely prescribed but remain susceptible to drug–drug interactions (DDIs) that increase bleeding or thrombotic risk. The real-world prevalence and factors associated with potentially clinically relevant DDIs in patients on chronic DOAC therapy require further study.
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