The Med Communications Pharmacovigilance (PV) department provides a dedicated team for scientific literature surveillance activities. In the United States, literature surveillance is required from the point at which a medicinal product receives marketing authorization. In Europe, weekly surveillance of the worldwide scientific and medical literature is required from the moment the marketing authorization request is submitted to the European Medicines Agency (EMA). We also offer literature surveillance for products in clinical trial stages that is tailored to each client’s needs and expectations.
Our literature surveillance support includes retrieval, assessment, and case processing of individual case reports from the scientific literature. We provide weekly reports regarding activities in the literature and the cases that have been retrieved for entry into the safety database and reporting to the regulatory authorities. In addition, we track relevant aggregate data and reports of special situations that are included in periodic safety update reports (PSUR) or for assessment during signal detection activities.
Our team has years of experience in the configuration of literature search terms for different medicinal products, including medical devices. We use online Embase and Medline databases for our standard literature search analyses. We also use a compliant software tool to track and retain all information pertaining to safety data received from the literature. We work in accordance with the Guidelines on Good Pharmacovigilance Practices (GVP) – Module VI and can assure compliance and audit readiness for our clients.