PubHive Automates Duplicate Detection for European Medicine Agency’s MLM Data
PubHive Ltd., a cloud-based scientific software company, today announced the availability of new automated duplicate database detection functionality for drug safety and pharmacovigilance (DSPV) teams that subscribe to the PubHive Navigator software-as-a-service (SaaS) platform and the Medical Literature Monitoring (MLM) service from the European Medicines Agency (EMA). Powered by a proprietary Omni-Loop AI Engine, PubHive Navigator now enables DSPV users that receive MLM reference results related to active substances and individual cases of suspected adverse reactions to automatically detect duplicate references that have been previously screened and submitted using PubHive Navigator, and also to add and initiate individual case safety report (ICSR) reviews for any new references.
“Detecting duplicate bibliographic references from MLM helps DSPV teams to keep their database clean, but more importantly to also prevent unnecessary duplicate regulatory reporting submissions by their company, MAHs, and literature vendors,” said Raj Vaghela, President and CEO at PubHive Ltd. “With PubHive Navigator, DSPV teams and vendors can further automate the MLM screening process, while simultaneously boosting traceability for all PV-performed work, audit-readiness, compliance and oversight.”
Scientific literature is an important source of information on suspected adverse reaction case reports. The European Medicines Agency (EMA) created the MLM service in 2015 in response to duplicative reporting of adverse reaction case reports by marketing authorisation holders (MAHs) in the European Economic Area that are obligated to monitor literature as outlined in the Good Pharmacovigilance Practices (GVP) guideline, Module VI 'Management and reporting of adverse reactions to medicinal products'.
Today, the EMA is responsible for monitoring a number of substances and selected medical literature, to help identify suspected adverse reactions to medicines authorised in the European Union (EU). EMA tracks relevant information in the EudraVigilance database, the European database for adverse drug reaction (ADR) reports that is used for monitoring the safety of all authorised medicines in the EU as well as medicines studied in clinical trials. In 2020, 1.8 million ICSRs related to suspected adverse reactions occurring in the post-authorisation phase were collected and managed in EudraVigilance. According to the 2020 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission, scientific literature screenings also gave rise to 18% of all potential signals in 2020.
PubHive is a cloud-based software company with a mission to make healthier literature and scientific information pathways for life science companies across all stages of the commercialization lifecycle – from discovery to post-market. PubHive Navigator™, the company’s scientific workflow automation platform, streamlines repetitive work and lowers costs and compliance risk for teams in pharmacovigilance (PV), medical writing, medical affairs, and information management.
For more information about PubHive and PubHive Navigator’s pharmacovigilance platform module Pulse, visit pubhive.com.
About PubHivePubHive™ (pubhive.com) is a cloud-based software company with a mission to make healthier literature and scientific information pathways for life science companies across all stages of the commercialization lifecycle – from discovery to post-market. PubHive Navigator™, the company’s scientific literature workflow and analytics platform, streamlines repetitive work and lowers costs and compliance risk for teams in pharmacovigilance, regulatory affairs, medical affairs and R&D. Powered by a proprietary Omni-Loop Artificial Intelligence (AI)™ engine, PubHive Navigator is the only 'fit for purpose' one-stop scientific literature platform today, distinguishing itself through flexible end-to-end workstreams and intuitive interfaces that make literature handling quick and easy.