Date: 28th February 2012
Time: 3PM London/ 10AM New York
Duration: 60 Minutes
Means of data collection and management; challenges in building, validating and submitting XEVPRM
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.