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REGULATORY AFFAIRS

IDMP

Keep your product data in control

Identification of Medicinal Products (IDMP) covers five ISO standards describing how to structure data on medicinal products according to defined information models. Companies with products or ongoing trials in the European Union will be required to submit data to the European Medicines Agency (EMA) once the IDMP standards have been implemented. The US Food and Drug Administration (FDA) is expected to follow. 

Be at the forefront of IDMP

IDMP aims to improve patient safety in medication and will soon become mandatory for every Marketing Authorisation Holder (MAH) operating within the EU region. To achieve IDMP compliance in the region, companies must comply with five ISO standards.

The collective goal for the standards (11238, 11239, 11240, 11615, and 11616) is to globally standardize the identification of medicinal products. Once EMA implements the new standards, FDA is expected to introduce the same requirements – making IDMP a worldwide standard.

Webinar: IDMP Revisited - The EMA implementation guide is out but what is your strategy?

Five steps to ensure compliance

IDMP will have a widespread impact on the preparation and planning of submissions and maintenance of data in life sciences companies – from manufacturing data and structured substance information to registration information throughout the lifecycle of a medicinal product.

To ensure compliance with the IDMP requirements, NNIT has defined five structured stages to enable timely cross-organizational compliance:

Impact Assessment

  • Identification of source fields, systems and gap analysis
  • Management reports
  • Project setup and scoping
  • Business case
  • IDMP vision

Business Preparation

  • Definition of project charters (systems, documents and gaps)
  • Architecture components
  • Data quality assessment
  • Implementation strategy

Opportunities & Solutions

  • Requirements specification
  • Implementation planning
  • Vendor(s) & solution(s) selection

Organizational Implementation

  • Source systems integration & modification
  • New supporting systems
  • Data capture
  • Implementation of IDMP solution
  • Submission

This phase is iterative

Hosting & Support

  • Hosting
  • Support
  • Application development

An efficient and timely process

The NNIT five-step model ensures an efficient and timely process from initiation to execution – and each phase is customized to meet the specific demands of your business and organization. We can help with everything from initial assessment to execution – and each of the individual phases in between.

NNIT can provide support in the implementation of IT solutions of all sizes; ranging from minor submission setups to full grown architectures with MDM components, data hubs and separate submission layer.

NNIT accelerators for IDMP systems

NNIT specializes in the technology of our partners. For each of these standard technologies, NNIT has developed a set of accelerators to ensure smooth implementation.

  • RMS Connection
  • Used for mappings
  • Monitor updates
  • IDMP Compliance
  • Dashboards
  • KPI & Metrics
  • Unstructured data
  • Fill the gaps
  • Input validation
  • ISO IDMP model
  • Navigate UI
  • Business readable

 

  • Standard workflows
  • Approval of change
  • Electronic signature

Business Preparation

  • Automated extraction of data from documents