Iperion is the leading expert on IDMP implementation
Iperion is at the center of the discussions with both Industry and Regulators

Iperion is at the centre of discussions with both Industry and Regulators - EMA, FDA, CBG MEB, SPOR Taskforce, Medicines for Europe, IRISS Topic group IDMP, NEN, ISO, IDMP Round table, AESGP, Efpia

Iperion is directly involved in:
  • the ISO IDMP discussion
  • review of the EU Implementation Guide (IG)
  • setup EU-Substance Registration System (EU-SRS)
  • leading IRISS forum
We have a proven track record with our clients for IDMP consultancy

Our approach to IDMP implementation

  1.  Awareness creation
    Iperion experts provide customized sessions which establish appropriate understanding on IDMP, its impact and benefits for all levels within your organization
  2. Maturity Assessment
    Together with you, we analyze your data, processes, organization and technology to define your future IDMP needs
  3. Planning & Setup
    We deliver a strategic vision for IDMP, based on best practices and fitting your unique business environment. Accordingly, we establish a pragmatic roadmap to implement your ideal solution
  4. Solution Implementation
    We support the implementation of the desired solution, while making sure that all stakeholders are appropriately engaged, and objectives are achieved
  5. Services
    We make sure that you have the correct and complete data for both development and registered medicinal products, comply with the internal and regulator needs. We can additionally strengthen and stabilize your maintenance operations by providing trained experts

 

Awareness creation: Training on IDMP requirements, standards, organizational impact and benefits; Training on EMA Master Data (SPOR); Workshop for Stakeholders; Regular updates from meetings with regulators. Maturity Asessment: Data mapping (availability, quality & consistency); Information flow mapping (process, organisation & technology); Data governance review; Process analysis; Gap analysis; Risk profiling and change readiness. Planning & Setup: IDMP vision & objectives; Business and IT strategy roadmap; Business case creation; Solution definition; Programme plan & setup. Solution Implementation: User Requirement definition; Vendor selection; System validation (CSV); Process and organizational (re)design; Data Governance set up; Quality documents & training manuals writing; Business & Quality Reporting; Solution architecture design. Services: Training; Data collection, mapping (MDM / SPOR), enrichment and verification; Data entry & maintenance; Data submissions; System maintenance


What is IDMP ?

ISO IDMP standards

IDentification of Medicinal Products (IDMP) is a data model, described in a set of five ISO standards and is used to describe the product and its characteristics.

IDMP…

  • provides structured medicinal, pharmaceutical product and substance data models
  • provides mechanisms to uniquely identify products and its components
  • is the only global standard for medicinal product information
  • is applicable to industry and regulators (in similar fashion as ISO 9001; Quality Management and other ISO standards)

IDMP is a global standard accepted by all 163 ISO member countries

 

Across the board industry stakeholders and health authorities are implementing IDMP. In the European Union this implementation is in the form of SPOR, Master Data Management product on Substances, Products, Organizations and Referentials.

SPOR data is meant to optimize the use of data across different processes (regulatory, pharmacovigilance, clinical, production, etc.) and IT tools (eAF, IRIS portal, CESP, CTA, EMVS, etc.).

Watch our webinar on how IDMP can be a pragmatic approach towards interoperability.

What is the impact of IDMP implementation for your organization?

IDMP will change the way of communication with the regulators.

Together with the current document-based submission, structured medicinal product data will be submitted, reviewed and approved during the regulatory activity.

time to start ISO IDMP implementation

To meet this change in requirement, your company will need to transition towards a data-driven organization, which can optimize internal processes and sharing of information between different technology solutions and departments.

Based on experience, we know that this transformation takes time, as it requires buy-in from multiple stakeholders, adaptation of processes and technological landscape. Therefore, it is paramount to start now!

With our experience in IDMP implementation strategies, regulatory operations combined with extensive production experience, we can support you in making sure that this transformation goes smoothly.

IDMP Request

Please leave your contacts and your question and we will contact you shortly

    Please refer to our Privacy Statement.

  • This field is for validation purposes and should be left unchanged.

Or contact us directly

via phone +31 73 648  8000 or send an email to contact@iperion.nl