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 Pharma eReport Blog

Date: 12th April 2012, by: Nicky
Tags: EVMPD, XEVMPD, ISO IDMP

Report: first meeting of IRISS IDMP Topic Group

We attended the first (virtual) meeting of the IRISS IDMP Topic Group last week, which set out the objectives of the discussion group in the run up to the July 2012 EVMPD compliance deadline.  The Topic Group has been established by the Implementation of Regulatory Information Submission Standards (IRISS) industry non-profit organisation to support the implementation of the International Standards for Identification of Medicinal Products (IDMP) but, in the more immediate term, to provide support and guidance for the implementation of the eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) in Europe.

Key representatives from the pharmaceutical industry and vendor communities came together to participate in the conference call, spanning operational areas from regulatory affairs and regulatory operations to technology development. One of the main Group objectives that was agreed upon early by all participants was that the Group will provide a really valuable platform to allow members to learn for the future – to start thinking about best practices, particularly as they will relate to the maintenance of records once submitted.

Discussion moved next to feedback on the use of the testing and production environments within the EudraVigilance Web Tool plus the EV Gateway, which the call  participants reported that they’d yet to test.  Overall, there were several teething problems reported with the registration process and very few people said that they had been actively testing.  Andrew Marr of Marr Consultancy (Leader of the IRISS IDMP Topic Group) noted the need for more online training opportunities and confirmed that online training is due to be available by the end of April.

The selected “hot topic” for the meeting surrounded Substance CV, and potential best practices to keep the substance CV “clean” and avoid any confusion regarding what are translations or synonyms rather than substances.  Following discussion, the group agreed to document some of the options and make a proposal to the EMA.

Hot topics identified for future meetings included discussions of controlled vocabularies for substances, the need for implementation guides, handling of languages in multi-language countries, and issues with MedDRA coding. One of the urgent issues that Pharma eReport raised on the call was the discrepancy between the XML schema issued by the EMA and the guidance notes, specifically in regards to which data elements are mandatory and which are not.  We suggested that that EMA should confirm if the schema is correct and welcomed further discussion and clarification on that key point.

The meeting concluded with the agreement that calls will be held every two weeks in the run-up to the crucial July XEVMPD deadline, which everyone welcomed.  We found the meeting hugely valuable and we urge anyone with an interest in the XEVMPD compliance process to join and contribute to this forum, that will hopefully continue to provide key guidance and frameworks for industry best practice as these standards roll out.

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