Annual International Congress IDMP & Regulatory Excellence 2016

Whereas some pharmaceutical companies are now already collecting data for future IDMP submissions, others are still in the preparatory phases, analyzing how to obtain data from different internal and external data sources. Depending on the outcomes of the analysis phase, especially the number and complexity of internal databases to be integrated, companies will decide for a solution architecture that is more or less able to integrate the data from wherever it resides; a wide spectrum of solution architectures – from stand-alone IDMP data bases, integral to integrated architectures will be chosen. This conference includes a workshop that aims to review and structure the data collection process in order to prepare for EMA’s First Iteration Phase next year. It will begin by walking through the IDMP data model in order to review the data that shall be provided in the different iterations and create a common understanding of the requirements. In some “hot spot” areas, the coding to be applied, the availability of relevant controlled vocabularies, the use of external databases, the involvement of internal or also external stakeholders will be discussed.