IDMP Consultancy

Iperion is the leading expert on IDMP implementation

Iperion is at the center of the discussions with both Industry and Regulators

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. Learn more about our managed services.

What is IDMP ?

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.).

Want to know more about ISO IDMP? We can provide IDMP Training for you and your team

Webinar ISO IDMP EU Implementation Guide

With the publication of the ISO IDMP EU Implementation Guide v2.0, the actual implementation clock becomes a reality.

The published guidance should give sufficient instructions to all involved parties: Regulators, Industry and Vendors to prepare. As IDMP has a significant impact on the organization and v2.0 provides more insights in the to-be established processes of submission of structured data with the regulatory activities (the Target Operating Model: TOM)

In March 2020 EMA published Iteration 1 of the ISO IDMP EU Implementation Guide. For this occasion we hosted the first webinar on the implementation guide. That recording is also still available.

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.

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.