IDMP - Use Case of a National Competent Authority, e.g. BfArM

January 13, 2016 10:00–11:00 Eastern Time (US & Canada)

The implementation of the IDMP standards will require a much more detailed data set than currently available from most of our databases. There are some major prerequisites before the implementation can become a success. Initially, controlled vocabularies need to be completed and must be used not only for an IDMP message but also for any application form submitted to agencies. BfArM is currently developing a new database to host all the metadata describing a medicinal product. We have to consider the most up-to-date data model, we have to make use of the European electronic application form (same data structure, interoperable) and we should modify business processes to realise benefits by reusing the same data for different purposes. This presentation will provide an overview, detail some challenges and define prerequisites as well as opportunities for achieving return on investment.

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