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Comprehensive data management for xEVMPD and IDMP compliance that includes seamless access to SPOR vocabularies

Article 57 Compliance for IDMP

Start managing your IDMP data with Phlexglobal today.

PhlexIDMP is a single regulatory database that will help you to avoid redundant data that exists within your submissions.  PhlexIDMP is based on two key components: controlled vocabulary management and codes that deliver the best ready to use IDMP management solution. 




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IDMP: What is it, and Why is it Important?

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IDMP stands for the Identification of Medicinal Products and is a general term used when referencing the collection of ISO data standards – ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240 – that are being refined and implemented by regulatory bodies in support of improving pharmacovigilance via the soon-to-be mandatory submission of this data to health authorities.

In comparison to xEVMPD (Extended EudraVigilance Medicinal Product Dictionary), the current legislative format, IDMP is substantially more detailed and complex.

By standardizing the structure and terminology used to describe healthcare products across all markets and all marketing authorization holders (MAH), the impact on health care delivery and patient safety has great potential:

  • Improved safety analytics across a broader spectrum of information
  • Globally identifiable product information
  • Complete product composition information
  • Enablement of information sharing between stakeholders






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New Developments in IDMP: What You Need to Know, and What You Can Do Today

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With the EMA expected to be the first health agency to mandate compliance with ISO IDMP (with the FDA not far behind), organizations face a rapidly shortening timeframe to prepare for this the highly complex compliance mandate.

Download Phlexglobal’s latest executive brief, “New Developments in IDMP: What You Need to Know, and What You Can Do Today.” You’ll benefit from our extensive compliance and technology expertise in life sciences, as well as Phlexglobal’s experience helping some of the world’s largest pharmaceutical companies prepare for IDMP.

Get the Brief

Seven Steps to IDMP

The challenge for a successful IDMP implementation is the fact that structured data output is required, while the data sources and existing data are typically unstructured. Therefore, a key element for a successful IDMP project will be a comprehensive data source analysis.

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To learn more, download our Executive Brief


IDMP and xEVMPD Submission Publishing

HL7 compliant submission publishing format. Publish test submission at any time. Optional push of final IDMP data into your master data management system.

  • Workflow guided by wizards

  • Directly connects to external databases such as GSRS, UCUM and EDQM

  • Edit data at any point in time during submission creation process

  • Manages xEVMPD submissions
  • Manages ISO IDMP submissions
  • Output format is compliant
  • Manages all relevant information for your pharmaceutical products
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  • Create reports with a few clicks

  • Gather regulatory overviews via filters

  • Conduct “what if analysis” for implication check reports
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Case Study: SmPC Data Mining Statistics & Savings

IDMP Case Study Problem & Preparation


Business Problem

  • Preparation for IDMP iteration I deadline
  • Increase compliance overall
  • Data Extraction from SmPC & eCTD M3 documents

Project Preparation

  • POC and System Evaluation 3-4 months
  • Cunesoft selected as technology vendor
  • Due Diligence / Vendor Audit / Contract Completion
IDMP Case Study Project Execution


Project Execution

  • Phlex-Distiller System Setup and Configuration
  • Training of Customers specific Extraction Algorithms
  • Implementation of Customer URS “Must-Criteria”
  • Data extraction from 1591 Customers SmPC’s in 26 languages (ca. 35 data entities per SMPC)
  • Data extraction from 272 3.2.P.1 eCTD M3 documents (substance data extraction)
  • MedDRA coding of extracted indications
  • Data curation of extracted data by Cunesoft data extraction team
  • Validation of data-sets to ~90% accuracy

Results: Statistics & Savings

  • 1591 SmPC’s in 26 languages
  • 100 eCTD M3 documents in English
  • Reduced Processing Time by factor 4-5
  • Included QC times results in higher quality
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Get the Details - Download the IDMP Data Sheet

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