Electronic PharmacoVigilancy (ePV): The new EMA guidance on EVMPD, will we meet the July 2012 deadline?
Klever and EXTEDO, the March 8, 2012 h.11: 00, organized a Webinar to explain the new EMA guidelines on XEVMPD. The interventions will be in Italian than in the English, who is interested can participate directly from their office using, simply, an Internet-connected PC.
The speakers will be Luigi Fabbro (Solution Manager, Klever) and Guenter Rodenkirchen (Account Manager, EXTEDO GmbH) and the webinar will last approximately one hour.
EMA is preparing the implementing of electronic submission for information on medicines. This applies to all Marketing Authorization Holders having medicinal products for human use authorized or registered in the EU. July 2012 is a major deadline to complete our product information e-submission. Afterwards, e-reporting of cases will be impossible if this preliminary phase is not completed. It is important to note that the e-submission of cases was voted by the EU parliament last year. A new format has been defined: the Extended Eudravigilance Product Report Message (XEVPRM), and the information to be passed on to EVMPD is extensively described in the detailed guidance.
- But how will Marketing Authorization Holders address this major step toward ePV?
- Do we have a clear understanding of the information required on our products and how to collect this information?
- How are we going to meet the deadlines in 2012 – internally, outsourced, a mix?
- Are our IT systems ready?
- What to expect after July 2, 2012?
During this webinar, we will address these questions and provide attendees with practical ways to meet this crucial deadline.
Klever and EXTEDO discuss the challenges in terms of IT consulting services and will conduct a demonstration of the solution Extedo MPDmanager.
Anyone interested to participate in the Webinar, you can request more information via email: marketing@k-lever.it or by calling Klever at 02-87286700.