Date: 28th February 2012
Time: 3PM London/ 10AM New York
Duration: 60 Minutes
Price: FREE
Means of data collection and management; challenges in building, validating and submitting XEVPRM
With the deadline for EVMPD submission fast approaching many challenges lie ahead, not just with the immediate submission by July 2012 but also with the on-going maintenance required after that date. EMA will be revising its guidance and providing FAQs. Experience on implementation and testing of tools will have been initiated and maybe some submissions actually made. Practical experience will be shared regarding the hot issues of the moment to assist MAHs in preparation for the intense activity of collation of data and submission of their EVMPD records in 2Q 2012.
Companies need to identify internal sources of information that needs to be submitted, and find a way to extract the data, gather it, transform and collate in the format described in EMA guidance documents. Further challenges can be foreseen in management of this data for future submissions in connection with Marketing Authorisation variations. Resources have to be identified, tools and processes must to be built and implemented to enable a smooth transition to a post-deadline period. Different approaches and strategies that can be taken in order to fulfill these requirements will be discussed.
INFOTEHNA eMPDExpertTM – tool for management of EVMPD information, building and submission of extended EudraVigilance Product Report Message (XEVPRM) will be demonstrated. Key elements and benefits of the tool will be highlighted, demonstrating how it’s predefined data model and implementation framework bundled with life sciences consulting services and existing data sources integration can help MAHs with the challenging task ahead.
Companies need to identify internal sources of information that needs to be submitted, and find a way to extract the data, gather it, transform and collate in the format described in EMA guidance documents. Further challenges can be foreseen in management of this data for future submissions in connection with Marketing Authorisation variations. Resources have to be identified, tools and processes must to be built and implemented to enable a smooth transition to a post-deadline period. Different approaches and strategies that can be taken in order to fulfill these requirements will be discussed.
INFOTEHNA eMPDExpertTM – tool for management of EVMPD information, building and submission of extended EudraVigilance Product Report Message (XEVPRM) will be demonstrated. Key elements and benefits of the tool will be highlighted, demonstrating how it’s predefined data model and implementation framework bundled with life sciences consulting services and existing data sources integration can help MAHs with the challenging task ahead.
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