Life Sciences Regulatory Technology

Emerging standards and trends on regulatory submissions for medical technology

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IDMP: It Deserves Many Purposes

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It’s a new year, and after a series of blogs last year where I delved into the finer nuances of IDMP, I believe it’s a good time to review just what it’s all about. IDMP (Identification of Medicinal Products – that set of ISO standards I keep talking about) began with a simple premise: Provide […]

IDMP: Increasing Delays Mimic PIM?

IDMP CSC Blogs

Before I go any further, let me answer the question in my somewhat tongue-in-cheek headline: No. IDMP (Identification of Medicinal Products) is not like PIM; it isn’t mired in controversy and stuck in idle. In fact, the situation with IDMP is quite the opposite to that of PIM (product information management). Yes, IDMP has suffered some […]

IDMP: Initial Delight Marred Prognostications

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Three and a half years ago, CSC published a white paper titled “Drug Product Registration Processes” (PDF) based on my initial analysis of the brand new ISO IDMP (Identification of Medicinal Products) standards, compared to the existing standards of the U.S. DLER (Drug Listings and Establishment Registration), and the European XEVMPD (Extended Eudravigilance Medicinal Product […]

IDMP/SPOR: Schedule Projection Other than Registrations

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Early in December, the European Medicines Agency (EMA) published a document titled “Transition Plan from Article 57/XEVMPD data submission to SPOR.” If you’re not deeply ingrained in life sciences submissions, you’re probably wondering what that mouthful of acronyms means. Here’s a breakdown: Article 57 is the EU law requiring medicinal product registration submissions. XEVMPD (Extended […]

IDMP: IRISS Demos by Multiple Participants

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On November 28, 29 and 30, from 10:00am to 11:30 a.m. EST, the IRISS Forum is hosting a Vendor Showcase for IDMP solution providers (separate sessions will be provided for service providers in the near future). Nineteen vendors will each have a 10-minute presentation on the solutions they have available (it’s unlikely you’ll see many […]

IDMP Lessons: What’s in a Name?

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I realized it’s been a while since I’ve provided any “how-to” information for IDMP (Identification of Medicinal Products), so it’s time for a new installment of IDMP Lessons. One of the more difficult sections of IDMP is the concept of the Product Name. This is the official licensed title of a product that would be […]

IDMP/SPOR: IRISS Distributes Many Pages/ Survey Provides Optimistic Results

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I’ve said it multiple times: if you want to follow what’s going on in IDMP (Identification of Medicinal Products), you absolutely need to be a member of IRISS. I have to give you the disclaimer that I’m currently serving a volunteer position in IRISS as vice president, but I get no compensation from the organization. […]

IDMP SPOR: Strong Presentation on Requirements

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On August 4, 2016, the European Medicines Agency (EMA) gave a web presentation on “SPOR Data Services” related to IDMP. For those of you who haven’t been binge-watching, IDMP is the Identification of Medicinal Products, a set of ISO standards describing every aspect of the life cycle of drugs and similar products (including herbals, homeopathic […]

IDMP/SPOR: Specifications Primarily Oriented for Regulators

On June 30 and July 1, 2016, the EU IDMP SPOR Task Force met in London at EMA’s offices Some highlights from the meeting…

IDMP: Immediate Delivery Milestone — Picklists

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In my last post I reported that the European Medicines Agency (EMA) had made some significant decisions regarding which fields will be required for the first iteration of the IDMP implementation (compliance expected around the end of 2018). This week, some additional important announcements were made: We now know what to put into several of […]