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 Pharma eReport Blog

Date: 14th March 2012, by: Nicky
Tags: EVMPD, XEVMPD, Centrality, software

Seven reasons to invest in an EVPRM system

Why should you invest in an EVPRM system if the EMA will be releasing a free one?  

Now that the race really is on to meet the July 2nd 2012 EVMPD compliance deadline, it’s a question that might occur to some Marketing Authorisation Holders as they start their vendor solution appraisals and selection process.  So, below is a brief response outlining why organisations need a vendor-supplied EVPRM system.  Here's seven reasons...

  1. The EMA system will not support your existing key business processes, such as efficient product life cycle management. The EMA system will not provide the capability to store past messages for you in a way that enables proper life cycle management and a robust audit trail.   A custom, professional-grade EVPRM system will offer a centralised database that efficiently tracks and logs all user activity, change tracking, and should also offer full harmonisation with your existing systems.  Additionally, with a custom system, the data can reside on your side and not with the EMA, allowing you to extract maximum value from your product information.
  1. The EMA tool will be a simple linear, web-form data entry tool – one allowing you to enter details for one MA at a time.   Our Centrality solution provides a choice of data entry options:
  • Simple fill-form: you can enter your Marketing Authorisation (MA) data sequentially, completing each section as needed. This solution follows the XML specification and documentation and is optimal for organisations submitting a small number of MAs (fewer than 10).
  • Library-oriented entry: our software offers the ability to build a structured library of core data elements, to be re-used multiple times to create multiple derivative MAs (for example, Organisation’, ‘Attachment’, ‘Source’, ‘Substance data’). This option works best for organisations with similar data to be entered into a large number of different MAs.
  • Batch import: we provide the facility to import XML or Excel files into our system. This method makes it easy to quickly incorporate data from legacy systems, and to create similar records from spreadsheet-format data.
  1. The EMA solution will offer no scope for custom integration.  Pharma eReport offers bespoke software integration development and can, in fact, create a completely bespoke interface for existing systems if needed, to help gather data from across your network and deliver a fully synched solution.
  2. The EMA system will not integrate into document management, tracking and version control systems. As a simple point tool, it offers no flexibility for this whatsoever, meaning that organisational product data maintenance will require much manual – and duplicate – effort.  Centrality offers full integration with such all document management systems, and also provides full relational database capabilities – meaning that when one data section is updated that will require several EVPRMs to be sent, user alerts for cross-system updates will ensure that these changes can be automatically and seamlessly propagated through the system.
  3. The EMA’s pharmacovigilance portal availability record has historically been very poor. In fact, as this is being written, the EMA PV web site is down again. This means that data entry is only possible on the EMA system during those periods when the system is actually running – and this schedule is unpredictable.  A custom system is backed by service level agreements that will ensure a minimum level of service and uptime, ensuring that no time is lost and delays incurred through unaccountable downtimes.
  1. The EMA has been offering a free Adverse Drug Reporting interface for years (WEB Trader and EVWEB), yet most clients have chosen to invest in custom software to capture, store and report ADRs – for many of the reasons given here.  
  1. And finally, our system is available and ready to help you now.  Request a Centrality demo today.

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