Category: IDMP

ARIM, EMA, IDMP

And if IDMP never happens?

Well, for one, it will. European Parliament has legislated that it must.  But it could come in many different forms, perhaps with nothing more than the minimal data to determine a Medicinal Product ID that gets used on an Adverse Event Report. That means the following items are the barest minimum of data that must be …

Conferences, IDMP

Speaker’s Corner June 2018

The big news right now is that at the last minute, Joel Finkle has been asked to speak as a substitute at the Q1 7th Annual Regulatory Operations and Submission Publishing Strategies Conference in Boston, June 14 and 15. I will be presenting an overview of IDMP, the EU approaches to implementing it, and how …

ACUTA, Conferences, IDMP

Join ACUTA at the eRegulatory Summit in Lisbon, April 24-26

ACUTA is proud to be presenting and exhibiting at Informa’s eRegulatory Summit conference at the SANA Hotel, Lisbon on April 24-26, 2018. Joel Finkle, ACUTA’s Director of Regulatory Innovation and IDMP Strategy will be speaking on the 26th, at 16:20, presenting “The RIM around IDMP – How to fill it up” with examples of data …

EMA, IDMP, SPOR

IDMP and SPOR: EMA Plans Published

One of the biggest concerns about implementation of IDMP in Europe has been that the plans were vague, and slipped frequently. European Medicines Agency (EMA) has just published a presentation with a detailed roadmap for the SPOR project and IDMP. The IRISS Forum also posted a summary of recent activity, but it’s limited to IRISS …

ARIM, EMA, IDMP

IDMPrimer: What we don’t know

IDMP Club

It seems the first rule of IDMP Club is the same as Fight Club: Don’t talk about IDMP Club (it’s probably the second rule too). I’m a member of some of the branches of IDMP Club, but not all. IRISS Forum probably has the most open exchange of information. I’d highly recommend joining if you …

CMC, FDA, IDMP, XML

FDA’s Draft CMC Data Elements – IDMP’s New Buddy?

On July 5, 2017, FDA (United States Food and Drug Administration) published a new document to the Federal Register titled “Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Technologies.” This is a draft document describing data structures that could take the place of much of the eCTD (Electronic Common Technical Document). Public comment is …

ARIM Registrations, EMA, IDMP, XEVMPD

XEVMPD: Unpacking its impact on IDMP

Note: This article is not a commitment to features or capabilities of ACUTA products or services. When ACUTA added the Registration module to to ARIM version 3.0 in 2017, our expectation was that IDMP (Identification of Medicinal Products, the ISO standards being implemented first in Europe) was imminent. Because of that, we expected it would …

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 …

EMA, IDMP, SPOR

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 …

ARIM Registrations, EMA, IDMP

IDMPrimer #1: The Four Quadrants of IDMP Data

Once upon a time, I’d written a number of lessons on IDMP – those are no longer easily available (hint: check out the Internet Archive, but come back here), and there have been changes, so let’s start from scratch. If you need a glossary of abbreviations below, please check out the April 25 blog post. …