Regulatory

The core driver of IDMP is to provide a common identification for drugs that can be referenced in Individual Case Safety Reports. The five ISO standards that make up IDMP create building blocks for storing product information and data; standardizing how routes of administration, dosage forms, and units are described; building in detail on active and inactive substances, and from there into pharmaceutical products (how things are consumed) into packaged products (how things are sold).

In 2012, five new ISO standards were approved to ensure unique identification of medicinal products and exchange between industry and authorities

  • ISO11615:2012 Health Informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information
  • ISO11616:2012 Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
  • ISO11238:2012 Health Informatics — Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated information on substances
  • ISO11239:2012 Health Informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
  • ISO11240:2012 Health Informatics — Identification of medicinal products – Data elements and structures for the unique identification and exchange of units of measurement

Why IDMP:

  • Adverse Events and drug interaction cases continuing to rise
  • Multiple Concomitant Medications taken by patients (1/3 of Americans over 65 take 5 or more drugs)
  • Claims of 700,000 Emergency Room visits 100,000 Hospitalizations (AHRQ PSNet)
  • Over 100,000 drug related deaths in U.S.
  • 197,000 deaths due to ADRs in Europe

Strategies for Compliance:

Eclipse IDMP support and consulting

  • Planning

     

    • IDMP workshop: overview,  timeline, standard data models and requirements
    • Worksheet review, company assessment
    • Gap analysis
    • Existing systems and process assessment
  • Project Initiation

     

    • Training of multidisciplinary groups as needed for specific functions
    • Gap analysis review and resolution options
    • Current System readiness: Analysis of structure
    • New system review and needs assessment, as required
    • User Requirements and solution architecture
  • Execution and Deployment

     

    • System Enhancement roll outs: Set up / interfaces
    • Validation,  as required
    • Data collection
    • Coding
    • Submissions to agencies
  • Maintenance

     

    • Ongoing Data Collection
    • Ongoing Coding
    • System maintenance
    • Compliance Surveillance

Our webinar, IDMP Readiness, what you need to know about July 2016, may be viewed online here.

Contact us for a diagnostic worksheet to assess your readiness and discussion on how we can assist your efforts towards compliance.

So What’s Next?

There are many factors in choosing a new Regulatory system and we talked about quite a few of them here. If you would like to explore your Regulatory software options further please schedule a consultation with one of our Regulatory experts.

Contact us today to learn more.
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