Overview

Medical literature is an important source of information on suspected adverse reaction case reports. As regulations are becoming more stringent, Marketing Authorization Holders (MAHs) may face the challenge of incorporating ever-increasing safety data into their Pharmacovigilance (PV) practices to achieve compliance. The quality and efficiency of the literature monitoring in the pharmacovigilance process have a significant impact on the quality of ICSRs, periodic safety reports, detection of new safety signals, and eventually Benefit-Risk Evaluation (BRE) of medicinal products. Importantly, shortcomings in the critical process of literature monitoring and literature screening pharmacovigilance processes have the potential to impact the MAH’s overall Pharmacovigilance activities. These activities include Regulatory compliance and have a potential impact on the company’s reputation due to inadequate Benefit-Risk Evaluation (BRE) of the products leading to potential drug recalls.

As a part of the literature screening pharmacovigilance process, Freyr assists organizations with specialized literature monitoring in pharmacovigilance services. Freyr’s team ensures the safety is monitored right from Medical Literature Monitoring (MLM), Global literature, and local literature review in identifying ICSRs to signals and information for inclusion in Periodic Safety Update Reports (PSURs).

 

Freyr Expertise

  • Global (Indexed) Literature Monitoring: Weekly monitoring of scientific and medical publications in global databases like PUBMED, Embase, Medline, etc. with specific search strings simplifying literature screening pharmacovigilance process
  • Extensive experience in developing robust search strategies for literature monitoring in the pharmacovigilance process
  • Local (Non-indexed) Literature Monitoring: Weekly/Monthly monitoring of scientific and medical publications across various local journals in respective countries in different languages
  • Weekly monitoring and reviewing of the Eudravigilance Medical Literature Monitoring (MLM) list, maintained by the European Medicines Agency (EMA), for ICSRs identified in the literature if the product(s) is(are) included in the list of active substances
  • Freyr Designed Application – Freyr Impact-L: : To streamline the literature management process, which is aimed to create a simple, customizable, and semi-automated literature review and tracking tool to help monitor safety and to meet the associated Regulatory requirements
  • Journal subscription services for literature review
  • Translation Services: Real-time translation services with ensured quality, in partnership with leading translation service providers for flawless literature review
  • Procuring Full Texts: One-click access to scientific literature, delivered within hours, right to the user’s inbox

Key Features of Freyr Impact-L