CSC Life Sciences responds with extensive EVMPD Resources including webinars, blog and dedicated Twitter feed
November 21st, 2011 - From July 2nd, 2012, pharmaceutical organisations marketing and selling drugs in Europe will have no choice but to comply with strict new requirements concerning the collection, reporting, coding and evaluation of medicinal product data, as part of the industry’s latest measures to minimise the impact of adverse reactions to drugs.
In an attempt to make product recalls immediate and effective, yet confined - to alleviate hysteria and minimise financial losses – the European Medicines Agency has mandated that, from next summer, life sciences organisations must gather a wealth of data on all of their products, which must be formally submitted to the health authorities in a standardised and structured way.
Specifically, organisations must adhere to the EudraVigilance Medicinal Product Dictionary (EVMPD), an agreed format developed by the European Medicines Agency in collaboration with the EudraVigilance implementation forums. The main objective of the EVMPD (which is explained in detail on the European Medicines Agency web site at http://eudravigilance.ema.europa.eu) is to ensure the robustness of pharmacovigilance activities across the European Economic Area (EEA).
The potential impact on pharmaceutical companies is enormous because of the sheer administrative burden this will place on them. Many companies simply don’t have time to get all the information together for the EVMPD - the necessary incremental skilled resources to search through their company data, to make sure they have everything in the right place and that it is correct.
Hoping for leeway as the deadline approaches next year is unrealistic, as the EMA has given no indication that it will allow additional transition time. “The EMA isn’t going to change the implementation date; it’s European law so companies have to determine quickly how they will ensure compliance,” notes Gillian King, head of global consulting, global professional services, at CSC Life Sciences.
Help is at hand, however. CSC offers a wealth of software solutions and managed services to alleviate EVMPD pressures on companies, and is tracking and reporting on developments through a regular blog on its web site. This valuable, up-to-date resource on EVMPD is moderated by Adam Sherlock, CSC’s Director of Life Sciences, who has deep experience in the pharmaceutical industry, registration tracking and other information management issues. It also features input from guest bloggers and industry experts. Companies can also stay abreast of the latest updates through CSC’s EVMPD-specific Twitter feed.
As a leader in regulatory submission and information management, CSC is fully equipped to respond to the EVMPD requirements, through targeted software solutions such as TRS Tracker, aimed at managing product and substance data, and via an extensive menu of data management services where CSC professionals take on the task of finding, collating and preparing pharmacovigilance-oriented data.
“We’re well positioned to work with our clients to determine where the information lies and develop a coordinated plan to consolidate this information together and submit to the EMA,” says Gillian.
Blog: Follow our blog at www.csc.com/evmpd
Twitter: For the latest updates, follow CSC’s Twitter-feed at @evmpd_news
Webinar: Register today for our latest webinar, Data Vigilance: Preparing for EMA's EVMPD Mandate running on November 17th at 3:00 PM central European time and 10:00am Eastern (New York City). Speakers include Gillian King, head of global consulting, global professional services, at CSC Life Sciences and pharmaceutical industry veteran Andrew Marr of Marr Consultancy. Register for the webinar here.
CSC is a global leader in providing technology-enabled business solutions and services. Headquartered in Falls Church, Virginia in the US, CSC has approximately 93,000 employees and reported revenue of $16.2 billion for the 12 months ended July 1, 2011. For more information, visit the company’s website at www.csc.com.
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