Medical Literature Monitoring (global and local)
Pharmacovigilance
According to GVP Module VI, medical literature is a critical source of safety information for monitoring the benefit-risk profile of medicinal products and detecting new safety signals or emerging issues. MAHs are required to conduct systematic, regular literature reviews across global and local sources to maintain up-to-date awareness of relevant safety data.
PVpharm offers comprehensive Medical Literature Monitoring services to identify relevant safety information at both global and local levels, in line with GVP Module VI.
Our services include:
- Global Literature Screening: Regular review of international scientific databases and journals (e.g., Embase, Medline) to identify ICSRs, safety signals, and relevant publications for PSURs, RMPs, and other regulatory deliverables.
- Local Literature Monitoring: Targeted monitoring of national and regional journals in the country where the product is authorised, in compliance with local health authority requirements (e.g., AEMPS in Spain, ANSM in France).
- ICSR Identification and Processing: Detection and triage of reportable cases from the literature, including data entry, MedDRA coding, narrative writing, and submission.
- Documentation and Audit Readiness: Preparation and maintenance of search logs, results, and justifications in line with GVP requirements to ensure transparency and inspection readiness.
- Custom Search Strategies: Design and validation of product-specific search strategies to ensure accuracy and relevance of retrieved literature.
- Duplicate Detection & Filtering: Review and management of duplicate literature entries across sources to avoid redundant processing and ensure efficient workflows.
