05 March 2012
EXTEDO: Webinar: The EMA Guidance on XEVMPD - Challenges and Solutions to Meet the Deadline in July 2012
Remco Munnik (Regulatory Information Director, ASPHALION)
Schei Dattner (Sales Director Global Account Team, EXTEDO)
Christian Kravogel (Product Manager, EXTEDO)
Starting Time & Duration
17:00 Central European Time (Barcelona, Munich, CET)
04:00 p.m., UK Time (London, GMT)
11:00 a.m., US Eastcoast Time (Philadelphia, EST)
08:00 a.m., US Westcoast Time (San Francisco, PST)
Duration will be about 60 minutes.
02 July 2012 is a major deadline to complete your product information e-submission to the EMA. A new format has been defined: the Extended Eudravigilance Product Report Message (XEVPRM), and the information that needs to be submitted to the EMA is extensively described in the detailed guidance.
But how will marketing authorization holders address this major step?
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?
During this webinar, we will address these questions and provide attendees with practical solutions to meet this crucial deadline.
ASPHALION will discuss the challenges from a regulatory service point of view including consultancy and staff augmentation through an outsourced service platform.
EXTEDO will present its new software solution MPDmanager, a Regulatory Master Data platform for XEVMPD and IDMP compliance. It supports applicants with an XEVMPD author system including wizard based data entry, it provides Excel & XML based interfaces for data import and export from various sources and it integrates with the EXTEDOsuite, product databases and other RIMS.
The registration for this webinar is free of charge. Please register online at: https://www3.gotomeeting.com/register/623688390