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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:
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Centrality software is fully compliant with EMA V5 schema updates and available now to pharmaceutical Marketing Authorisation Holders
Cambridge, UK, September 15th 2014 – Pharma eReport, a software and services company that delivers a comprehensive XEVMPD compliance solution for pharmaceutical regulatory professionals, today announces that its Centrality software is fully compliant with the latest XEVMPD schema changes mandated by the European Medicines Agency (EMA). Centrality offers Marketing Authorisation Holders a straightforward mechanism to import existing product data, update it to the new V5 schema and submit it to the EMA. The software has been successfully managing the re-submission process for customers since the V5 update came into force on 16th June 2014. Prospective users can register for a free online demonstration now at http://www.pharmereport.com.
On January 31st 2014, the EMA substantially changed the requirements for the product data that pharmaceutical companies must submit to the Eudravigilance Medicinal Product Dictionary, or XEVMPD. All Marketing Authorisation Holders (MAHs) must have updated their product records in accordance with the EMA’s “V5” guidance by December 31st 2014. The mandatory changes are being made to address a range of issues on the road to the implementation of ISO IDMP (Identification of Medicinal Products) in 2016, including new information required to support the assignment of pharmacovigilance fees, improvements to the quality of submitted data, and modification of controlled vocabularies.
Pharma eReport’s quality-assured, V5-compliant Centrality software is being used today by major global pharmaceutical companies to manage ongoing XEVMPD compliance. Built directly from the EMA schema to ensure syntactically correct EudraVigilance Product Report Message (EVPRM) messages by construction, Centrality also incorporates built-in business rules, so that the entire process – from data entry through to submission to the EMA gateway – is error-free, continuously cross-checked and seamlessly compliant.
Pharma eReport’s solution offers extensive data import capabilities and transparently interfaces with customers’ existing data systems. With the additional option of a full range of specialist support and consulting services, Pharma eReport enables customers to outsource the entire XEVMPD compliance process.
Commenting on today’s announcement, Marco Rubinstein, CEO of Pharma eReport said: “Our Centrality software is being embraced by major pharmaceutical companies as a technically superior, cost-effective and proven solution to achieving and maintaining XEVMPD compliance.” He added: “Since our solution has been engineered from the ground up to be both agile and highly robust, we have been able to very quickly adapt our system to the requirements of the V5 update. Whether MAHs are currently using the EV web tool, a different software solution, or even have yet to submit any data to the EMA, we provide a complete, easy-to-implement and fully tested solution for Article 57 compliance that minimises the administrative burden and keeps pace with evolving specifications.”
The Centrality software is offered via a transparent pricing model and with fully flexible deployment options. The Centrality platform is available as a secure, on-demand cloud-based application (Software-as-a-service) accessed via a standard web browser, or it can be installed as a standalone software application. For customers who wish to have all their data in-house, Centrality can be installed on a company intranet, so that the data is held on-site and authorised users can access it securely via the company system. The Centrality software solution is completely independent – no other software needs to be installed – and offers full support for both Windows and Linux.
To sign-up online for a free demonstration of Pharma eReport’s Centrality software, please visit: http://www.pharmaereport.com