PhlexEVMPD

Extended Eudravigilance Medicinal Product Dictionary Software

Improve your efficiency and experience better compliance with our user friendly and comprehensive xEVMPD software for managing your medicinal product information

Extended Eudravigilance Medicinal Product Dictionary

 

 

 

 

What is xEVMPD and who must comply?

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.

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Your xEVMPD Submissions with Phlexglobal

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Easy to Use

User friendly interface, that helps acclimate users to the system quickly.                                                                                                                                                                                                                                                          

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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

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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.                  

 
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Get to know your future xEVMPD software!

 

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RECEIVE

1st, 2nd & 3rd acknowledgments from EMA via the gateway quickly!

  • 3rd Acknowledgement from EMA will be visible on your publishing screen
  • The changes expected from EMA in teh 3rd acknowledgement can be applied in the "My tasks" screen of the product owner. Once you apply option "Apply changes" you will see your changes in your product management screen. 

 

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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.

  • Your drafted Product will be going through an approval process. If there are any problems with the information added, a missing validation information message will pop up on your screen. 
  • Once you assign an approver for your task, tasks will be displayed in the list
  • When choosing a task from the task list, product information will pop up to "Approve" or "Reject" the task. 
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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.

  • In the Product Detail on can check details in the MeDRA dictionary browse window.
  • Such details could be a Drug Indication and the manufacturing sites. 
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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!

  • Bulk edit the "Product" selected from the Product list screen.
  • Once changes are made - they should be updated in the "Product" selected for the Bulk Edit. 
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Get the Details - Download the PhlexEVMPD data sheet! 

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