ARIM Registrations, EMA, IDMP, SPOR

IDMPrimer #3: Building Blocks

So far in the first two primer posts I’ve described some over-arching concepts about the data that goes into IDMP, how it’s used, and where it comes from. Let’s start piecing things together and understand what an IDMP message would look like. I promise not to use XML for now – the HL7 Structured Product Language …


IDMPrimer #2: EMA’s Operating Model

Last time, the subject was the overall data in IDMP (The ISO standard for Identification of Medicinal Products), and how it grouped into regulatory vs non-regulatory, and the description of the product itself versus what it’s authorized for. This lesson is about how all that data is going to be used, and how that influences …


Would you support IDMP that isn’t IDMP?

Joel Finkle, Director Regulatory Innovation & IDMP Strategy For the last few months – both at the January and March EU IDMP/SPOR Task Force Meetings, there has been debate about how to send IDMP data to agencies in Europe. Although the ISO standard specifies the HL7 SPL format, the initial iteration of EMA’s implementation is …