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Pharmacovigilance is a generic term for all activities related to the monitoring of the safety of medicinal products or the detection and prevention of drug risks in the clinical trial phase and after approval.<\/p>\n
The World Health Organization (WHO) defines pharmacovigilance as the science and activities related to the detection, assessment, understanding and prevention of adverse drug reactions or other drug-related problems and risks.<\/p>\n
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In recent years, the regulatory requirements for marketing authorization holders in the area of pharmacovigilance have increased significantly at both European and national level.
\nAccordingly, we have continuously expanded our range of pharmacovigilance services over the past 20 years in order to efficiently support you in fulfilling your obligations: <\/p>\n
Pheda – E2B-compliant PV database<\/u><\/strong><\/a><\/p>\n Our pharmacovigilance database Pheda provides you with a structured, online-based management of adverse reaction reports – including the creation of line listings and extensive query options – and you can also use the gateway to exchange reports with authorities and partners.<\/p>\n Literature research \/ evaluation – PhedaLit<\/u><\/strong><\/a><\/p>\n Since 2005, structured literature research and evaluation has been a central pharmacovigilance service component of Heacon Service GmbH. In Heacon’s own validated literature database PhedaLit, customer-specific literature citations are compiled in a structured manner in the company’s own database accounts. MLM<\/u><\/strong><\/a><\/p>\n Since 2015, we have been offering you the specific “Medical Literature Monitoring” service package as a targeted supplement to the literature research and evaluation of the pooling project. EVDAS & EVWEB <\/u><\/strong><\/a><\/p>\n With the PV tools “EVDAS” and “EVWEB”, we offer you specific services for the structured, drug-related screening of EVDAS and the routine screening of EVWEB cases.<\/p>\n PSURs<\/u><\/strong><\/a><\/p>\n Depending on your company-specific requirements, we offer you both the creation of individual, “ready-to-submit” Periodic Safety Update Reports (PSURs) and cross-company, pooled PSURs in the form of PSUR templates.<\/p>\n PSMF<\/u><\/strong><\/a><\/p>\n The Pharmacovigilance System Master File (PSMF) is of central importance as pharmacovigilance master documentation. Signal management<\/u><\/strong><\/a><\/p>\n Heacon’s own signal detection tool Signal Sentinel\u00ae simplifies the recording, evaluation and documentation of signal detection processes. PV audits<\/u><\/strong><\/a><\/p>\n Whether as a component of your company’s own quality management, in preparation for an official inspection, as an internal training measure or as a consulting measure on the occasion of regulatory changes – our qualified team of auditors has developed a specific pharmacovigilance audit program that focuses on the regulatory requirements as well as the specific needs of your company.<\/p>\n
\nThe pooling project is based on the shared use of generally available data relating to active substances, which results in considerable cost savings for the individual MAH. <\/p>\n
\nAutomatic digital notification when new entries are added ensures that you are always informed. <\/p>\n
\nWe regularly screen the EMA database using specific search strategies and filter the relevant EMA results according to customer specifications. <\/p>\n
\nDepending on your company’s specific needs, we can create a fully comprehensive PSMF for you in accordance with the regulatory requirements – including the annexes – or provide you with selective support in reviewing and revising the SOPs and describing pharmacovigilance-specific processes. <\/p>\n
\nIt is used to create both initial and routine reports. <\/p>\n