DRUG DISCOVERY AND DEVELOPMENT 19
Fig. 1. Adherence to EVMPD requires data concerning the collection, reporting, coding and evaluation of medicinal product data.
Source: BASF
Rising to the challenge of EVMPD
Sean Ottewell looks at the latest information management systems to administer new requirements concerning the collection, reporting, coding and evaluation of medicinal product data.
Sean Ottewell observe les systèmes de gestion de l’information les plus récentes pour gérer les nouvelles exigences en matière de collecte, de compte-rendu, de codage et d’évaluation des données de produits médicaux.
Sean Ottewell nimmt die neuesten Informationsmanagementsysteme für die Verwaltung neuer Anforderungen an die Erfassung, Auswertung, Kodierung und Nutzung von Arzneimitteldaten unter die Lupe.
F
rom 2nd July 2012, pharmaceutical organisations marketing
and selling drugs in Europe have no choice but to comply with strict new requirements concerning the collection, reporting, coding and evaluation of medicinal product data, as part of the industry’s latest measures to minimise the impact of adverse reactions to drugs (Fig. 1). Specifically, organisations must adhere to the EudraVigilance Medicinal Product Dictionary (EVMPD).
“CSC stands apart as the one solutions provider to offer complete
managed-service systems that ensure companies’ readiness to meet the EVMPD mandate. Te timelines are too tight for companies to wait for fully integrated regulatory information management tools to come on the market, let alone have them implemented and validated in time. Te collection planning and the actual collection of company data have to start now, and CSC is prepared to host, manage and deliver EVMPD messages for clients,” says CSC Life Sciences director Adam Sherlock.
CSC tailors submission strategies to suit clients’ needs and organisational structures. Whether a pharma company’s management of its regulatory information is centralised or decentralised, CSC can create the most efficient way of getting the information together for EVMPD messages.
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