The continuous monitoring of the data held by the EudraVigilance database is one of the main new challenges that marketing authorisation holders face since go-live of the new EudraVigilance System on Nov. 22, 2017.
EudraVigilance provides huge datasets of drug/event combinations. Although the legal obligations are the same for Big Pharma and for small- and medium-sized companies, the means and options for screening EudraVigilance differ with respect to their resources (e.g. men power or automated IT solutions). Also, the guidelines allowing the creation of a compliance-focused approach are barely available.
After briefly summarising current expectations of the EMA and national competent authorities, the main focus of the talk is on the EViSiMa® approach (EudraVigilance-based Signal Management) that supports especially small- and medium-sized companies in achieving compliance with respect to safety monitoring of the EudraVigilance database. Besides outlining the basic EViSiMa® process, its opportunities and major advantages are highlighted, as it aims to provide a cost-effective procedure for APIs authorised by a single MAH or shared by multiple MAHs.
After Claudia Nowak joined the medical science and pharmacovigilance department of Dr. Ebeling & Assoc. GmbH in 2017 – an experienced pharma consultancy for medical science, medical affairs and pharmacovigilance services – she participated in the development of the EudraVigilance-based Signal Management (EViSiMa®) project, and became the lead from the medical science perspective starting with the availability of EVDAS on 22.02.2018. Prior to this, she successfully graduated in biochemistry, which will be complemented by a PhD in the field of biotechnology/biocatalysis. The focussed work on opportunities regarding efficient monitoring of the data contained in the EudraVigilance database represents the basis for her collaborative operations in supporting especially pharmaceutical SMEs in terms of achieving compliance with respect to safety monitoring of the EudraVigilance database.