IDMP COMPLIANCE

Greater pharmacovigilance with
EU-wide medicinal product identification!

IT Compliance

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
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WEBINARS AND EVENTS

08. November
German Webinar

Prüfmittelverwaltung und -überwachung mit SAP

Vorstellung der in SAP integrierten Prüfmittelverwaltung mit allen Funktionen für die unternehmensweite Verwaltung betrieblicher Prüfmittel

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12. November
English Seminar

SAP: Validation and GMP Compliance

Seminar with speakers from DHC GmbH, organized by Concept Heidelberg on behalf of the ECA Academy, Steigenberger Hotel Berlin

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22. November
German Webinar

Validierung von SAP S/4HANA Enterprise Management

Neue Compliance Aspekte und Wege zu SAP S/4HANA sowie Vorstellung der prozessorientierten, risikobasierten DHC Methode auf Basis von SAP Activate

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29. November
German Webinar

APQP, FMEA und PLP mit SAP QM

Vorstellung der verschiedenen SAP Werkzeuge zur Abbildung von APQP und Darstellung von SAP PPM, FMEA, Kontrollplan, Prüfplan und Qualitätsmeldung

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06. Dezember
Webinar

SAP QM als integriertes Laborinformations- und Managementsystem (LIMS) in der Life Sciences

Vorstellung von LIMS-Funktionen des SAP QM sowie Integrationsaspekte zu Einkauf, Lagerung, Produktion und Vertrieb

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