EMA data migration plan to PMS

On February the 23rd, EMA organized a webinar about the migration of the data from their SIAMED and xEVMPD databases.

SIAMED data has been migrated according to the rules given in Chapter 7, while xEVMPD data copy is planned soon. However, none of those databases contains the full set of data required by the IDMP/PMS model. It will be then up to the pharma companies to complete the missing information. For the larger ones, those who have lots of registered products, this task will be huge and risky, since EMA only proposes on the short term manual data entry via their site. To decrease those risks, EMA is starting to develop an API connector based on the FHIR protocol that would allow the companies to plug in their own local RIMS databases and automate the transfer of the missing data.

This will represent a key milestone for the IDMP implementation, and both the industry and the editors are eager to get all the specifications ready to finalise the setup of their systems. No date was provided by EMA so far for the availability of the API.

You will find a link to the official EMA page here.