News/Events

Thursday 27 October 2011 GoToWebinar: electronic Pharmacovigilancy - the new EMA guidance on EVMPD (July 2011), will we meet the July 2012 deadline?


This Webinar will be run by Extedo and ProductLife Group.


EMA is preparing the implementing of electronic submission for information on medicines.

This applies to all MAH having medicinal products for human use auhtorized or registered in the Union whatever procedures and 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 and remember that e-submission of cases has been voted by the EU parliament at Autumn 2010. 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 MAH will face this major step toward ePV? Have we a clear understanding on 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?

Duringthis event, we shall target these questions under two approaches:

ProductLife Group will present you the vision to the above challenges from a service view including consultancy to staff augmentation through outsourced service platform.

 

And EXTEDO will further highlight how a regulatory information management software solution can make your work easier with an insight into the EVMPD standard from a technical view and a presentation of its strategies and tools for supporting applicants.

 

The purpose is to show you practical ways to meet this crucial deadline.

 

Registration conditions

After registering you will receive a confirmation email containing information about joining the Webinar.The registration for this webinar is free of charge. Please register online at: https://www3.gotomeeting.com/register/715663526

 

We are looking forward to your participation.

Event date: 27/10/11 16:00 to 17:15
Location: Online

 

Latest News

Wednesday 20.06.2012
Kostenloses Business Frühstück in München: „Regulatory Information Management System“ (RIMS)
Read more

Tuesday 12.06.2012
Webinar France - Soumission réglementaire : nouveautés et innovations Démonstration SharePoint
Read more

Wednesday 06.06.2012
Congres Montpellier: Rendez-vous au congres SFSTP 2012!
Read more