Connected
Connects your external business partners (i.e. CRO’s, CMO’s etc.) via a secure data management Portal to have them share their xEVMPD-relevant data with you.
xEVMPD or Extended EudraVigilance Medicinal Product Dictionary is a database (xEVMPD database) designed to support the collection, reporting, coding and evaluation of medicinal product data in a standardized and structured way. The information is utilized by the European Medicinal Agency (EMA) & European National Authorities for all authorized medicines in the Europe in support of Article 57 requirements.
xEVMPD’s purpose is to collect the data of the medicinal products that are already existing or still in development. This collected information is used for evaluation of adverse reactions during the new drug development and for following the marketing authorizations of medicinal products within Europe.
Submitting medicinal product information by xEVMPD standards has been mandatory since 2012 and is still required today. All marketing authorization holders (MAHs) and sponsors of clinical trial must submit information to xEVMPD database.
Easy to Use
User friendly interface, that helps acclimate users to the system quickly.
Compliant
Compliance with Article 57, FDA 21 CFR Part 11, GxP Processes, EMA/717178/2011, EMA/800577/2011, EMA/327516/2011, EMA/135580/2012, EMA/718844/2011, EMA/661709/2014
Connected
Connects your external business partners (i.e. CRO’s, CMO’s etc.) via a secure data management Portal to have them share their xEVMPD-relevant data with you.
RECEIVE
1st, 2nd & 3rd acknowledgments from EMA via the gateway quickly!
VALIDATE
Before submitting, ensure your information is complete and internally approved using built-in workflows that are quick and painless! Plus, view your overall submission status via standard reports that you can personalize, save and share.
MANAGE
your controlled vocabularies that are implemented in the system. EMA libraries including ATC, Medical Device Organizations, Pharmaceutical Dose Forms, Routes of Administration, Substances, Units of Measurements, Le Basis, Medicinal Product Types, Authorisation Procedures/Status/Types. Plus automated comprehensive MedDRA coding.
FACILITATE
workflow driven processes such as xEVMPD data approval and xEVMPD submission approval. Efficiencies when working with multiple revisions. cune-xEVMPD enables bulk submissions & bulk updates to save time!
UK: +44 (0) 1494 720420
US: +1 (484) 324-7921
Poland: +48 81 45 46 132
Germany: +49 89 23514741
E-Mail: info@phlexglobal.com