Webinar: The EMA Guidance on XEVMPD - Challenges and Solutions to Meet the Deadline in July 2012

ProductLife, epista IT & EXTEDO would like to invite you to a joint webinar on covering the new challenges related to the EMA guidance on XEVMPD. This webinar is especially for customers from the Nordics & UK, but of course all customers are invited to participate independend from where they are.

Speakers:

• Klavs Ejsberg (CEO, epista IT)
• Katrin Spaepen (Managing Director Benelux/Scandinavia, ProductLife)
• Christian Kravogel (Product Manager, EXTEDO)

Starting Time & Duration

• 14:00 European Time (Copenhagen, GMT+01:00)
• 01:00 p.m., UK Time (London, GMT)

Duration will be about 70 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?

ePista IT will shortly describe the experiences implementing IT systems like MPDmanager. Furthermore the future strategy of IT compliance services in a regulated and uncertain industry will be presented.

ProductLife 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.

Registration:

The registration for this webinar is free of charge. Please register online at:

https://www3.gotomeeting.com/register/715095326

We are looking forward to your participation.

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