IDMP COMPLIANCE

Greater pharmacovigilance with
EU-wide medicinal product identification!

IDMP COMPLIANCE

Every effort is being made to harmonise standards within the European Union. One such area of harmonisation is the identification of medicinal products (IDMP) in the European market.


The central idea behind IDMP is to add more detail to the information available for medicinal products on the market, with a special focus on their composition and pharmacovigilance. To implement this IDMP initiative, the EU is consolidating five ISO standards, The IDMP initiative must be put into practice by affected pharmaceutical companies no later than the implementation deadline.

SPOR is a database that is essentially based on data points for Substances, Products, Organisations and Referentials (SPOR). The SPOR database lies at the heart of IDMP and, thanks to its comprehensive network of information, permits a comprehensive understanding of pharmacovigilance and impacts on the health of the population. The core information that can be utilised from the four SPOR domains can be summarised as follows:

Substances:
Harmonisation of data and definitions to ensure the uniform identification of the ingredients and substances used in medicinal product formulations.

Products:
Harmonisation of data and definitions to ensure the uniform identification of medicinal products in a legal context (such as market launch, packaging, patient information leaflet)

Organisations:
This data is intended to describe the organisations involved, alongside their business partners, covering the process chain from manufacturing through to market approval.

Referentials:
A list taken from a defined vocabulary to describe the properties of a product, such as its dose, units for measurement, etc.

To implement this ambitious project, which aims to deploy SPOR as a centralised master data platform, a distinction is made between the following four services:

  • Substance Management Services (SMS)
  • Product Management Services (PMS)
  • Organisation Management Services (OMS)
  • Referentials Management Services (RMS)


DHC CONSULTING SERVICES FOR IDMP COMPLIANCE

Consulting

Our team is happy to help you make the necessary preparations for the transition to SPOR as the first two services go live: RMS and OMS.

The key challenges for businesses here are as follows:

Prioritisation:
We identify the most important key positions in your company where the influence of IDMP will be most strongly felt. We take a structured approach to working on individual priorities and communicating these clearly to the key positions/departments at an early stage. One specific priority here is the data management system for the entire IDMP dataset.

Process adjustment:
We take a close look at all of your data management processes, so as to make any necessary modifications at both a global and local level. This approach can also be utilised for the harmonisation or standardisation of the affected processes. We also recommend synchronising the local data as well for RMS and OMS.

System adaptation:
Typically, the process adjustment stage will also affect the systems in place at your business and their architecture. We analyse the system architecture and adapt this as necessary to the new processes and requirements.

Data collection:
At this stage, we help you with preparation and execution. We work with you to develop an approach that draws the right conclusions from the first SMS and PMS go-live, using this as the basis for continuing with data collection for RMS and OMS.

WHY CHOOSE DHC?

Make use of our experience and industry expertise as IDMP specialists!

  • A wealth of expertise in regulatory requirements
  • Broad-based experience with a very wide range of IT systems
  • Integrative approach adopted for existing QM systems
  • High level of knowledge transfer
Germany
Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com

Matthias Bothe, DHC GmbH
Switzerland
Carsten Buri

Director Sales & Marketing
phone: +41 44 500 888 7
email: carsten.buri@dhc-ag.ch

Carsten Buri, DHC AG
Request information!

Learn more about our consulting services for GxP Compliance!

CUSTOMERS

WEBINARS AND EVENTS

16. April
Webinar (in German)

VxP, the cloud-based Validation Platform for the Life Sciences

With VxP, DHC offers a cloud-based validation platform to accelerate validation processes and digitalise documentation.

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22. April
SAP QM Online Info Day

Boost your Quality Management

On the topic of “Integrated QMS”, the SAP partners, DHC and SSE, will present current concepts and use cases at the online info day on 28 April 2021.

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23. April
Webinar (in German)

SAP S/4HANA Deployment Options for Life Sciences (Cloud vs. On-Premise)

This webinar looks at the different SAP S/4HANA deployment options from the perspective of regulatory requirements in life sciences.

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28. April
Online Info Day

Digitalisation of the computerised systems validation (CSV)

In this CSV online info day, we explain the characteristics, possibilities and challenges of digital validation.

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30. April
Webinar (in German)

Using SAP Fiori Apps for QM in ECC 6.0

This webinar will introduce SAP Fiori Apps for QM and how they can be integrated into an SAP system that has not yet been converted to S/4HANA.

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06. Mai
Webinar (in German)

UDI: Implementing global requirements with the right strategy and software

Implementation of the UDI requirements based on the SAP Cloud Platform with the UDI Platform of projektraum36

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07. Mai
Webinar (in German)

IT Compliance Framework – Your key to digital validation

Presentation of the structure and essential contents of the IT Compliance Framework and description of the possibilities of use.

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11. Juni
Webinar (in German)

QM implementation as part of the digitalisation strategy at Medartis AG

Learn how we have optimised important core QM processes in the course of digitising production and introduced them on the basis of SAP QM.

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25. Juni
German Webinar

Which QM functionalities does S/4HANA 2020 offer and which not?

Free webinar about the standardized DHC method for software evaluation using the example of QM in S/4HANA.

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09. Juli
Webinar (in German)

QM in S/4HANA – Example of an integrated LIMS in a Customer Project

Presentation of the quality-relevant processes of a LIMS in a customer project with the help of SAP QM as an integrated overall solution.

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09. November
Life Online Training

SAP: Validation and GMP Compliance (Live Online Training der ECA Academy)

Online training with speakers from DHC GmbH, organised by Concept Heidelberg on behalf of the ECA Academy,

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DHC WEBINARS

Our webinars are provided as a free service for DHC customers and potential customers.