Reporting of adverse events ONLY

Patients should always seek the advice of a doctor or pharmacist in case of adverse events.

If you wish to report an adverse event to ELC Group s.r.o., please find the contact information below:

00420 224 910 672

(from 09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

To contact us about any other issue please call:

+420 22 491 0000or our regional offices.

Hlášení nežádoucích príhod

Pacienti by meli vždy požádat o radu svého lékare nebo lékárníka v prípade výskytu nežádoucích príhod.

Pokud chcete nahlásit nežádoucí príhodu spolecnosti ELC Group s r.o., prosím využijte kontaktních údaju níže:

00420 224 910 672

(09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

Pro záležitosti, které se netýkaji farmakovigilance, kontaktujte prosím recepci:

+420 22 491 0000 nebo naše další pobočky.

XEVMPD software provider Pharma eReport launches Excel Data Import Service

New “Collate, Convert & Comply” service imports, checks and converts Microsoft Excel Spreadsheet data to compliant XML format

Cambridge, UK, June 12th 2012 – Pharma eReport, a software and services company that delivers a comprehensive EVMPD compliance solution for pharmaceutical regulatory professionals, today announces the launch of its “Collate, Convert & Comply” Excel spreadsheet data import service, which enables Marketing Authorisation Holders to quickly and easily import MA spreadsheet data into Pharma eReport’s Centrality XEVMPD software and convert it to compliant, syntactically-correct XML format. Pharma eReport has also made its Excel spreadsheet for data entry freely available on its website.

The new “Collate, Convert & Comply” service expedites data entry for Marketing Authorisation Holders and pharmaceutical regulatory professionals, providing total data import flexibility. The service is offered with custom interface and import capabilities, which gives MAHs the option to either import entire spreadsheet-based Marketing Authorisations into Centrality – Pharma eReport’s comprehensive EVMPD software suite – or to import whatever MA data is held in spreadsheet format and then complete it manually within the Centrality platform.

The two-stage import process begins with an initial population of Centrality’s ‘Element’ library from the spreadsheet data. The imported data is automatically de-duplicated against existing entries and data elements in the database, to ensure robust lifecycle management – meaning that if a data element changes in the future, all dependent EudraVigilance Product Report Messages (EVPRMs) will be automatically flagged for re-submission. In the next stage, the EVPRM is constructed by gathering all the data elements as described in the imported spreadsheet, ready for compliant submission to the European Medicines Agency (EMA).

A key additional service feature is the built-in ability for customers to request auto-translation of individual Controlled Vocabularies descriptions to the appropriate EV code. The Centrality tool has been designed from the ground up for ultimate flexibility in providing accurate and seamless custom translation.

Commenting on today’s announcement, Marco Rubinstein, CEO of Pharma eReport said: “With the 2nd July 2012 EVMPD deadline fast approaching and Marketing Authorisations Holders now heavily involved in the huge data collation effort that compliance requires, our goal is to make the data entry process as smooth and hassle-free as possible for our customers.” He added: “Many of our customers hold data which they have extracted from their current pharmacovigilance software – often from more than one system – and usually output into Excel format. Our new “Collate, Convert & Comply” service relieves customers from having to tediously re-enter all this data, and provides a fast, easy and flexible service that is custom-engineered to interface with their existing systems and processes.”

To sign-up online for a Centrality software user account and to register interest in Pharma eReport’s “Collate, Convert & Comply” service, please visit: http://www.pharmaereport.com