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ISO IDMP

ARE YOU READY FOR ISO IDMP?

1 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 ISO 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. 

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:

Deep insight and extensive experience

NNIT is represented in the ISO TC215 WG6, the International Organization for Standardization's (ISO) Technical Committee on health informatics. As part of this collaboration and participation in the EU SPOR Task Force with EMA, NNIT is involved in the roll-out of IDMP in Europe and has performed more than 20 IDMP projects since 2013. 

NNIT has a deep understanding of the requirements and processes required to move an entire pharmaceutical company from its current state to IDMP compliance – while ensuring smooth organizational change management (OCM) throughout each phase.

Leverage our knowledge and expertise to execute IDMP compliance in your organization by: 
  • Choosing the right solution for your organization 
  • Ensuring smooth and problem-free implementation
  • Integrating existing IT systems to form IDMP-compliant records
  • Training your team members to understand and host the solution

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

NNIT Accelerators for IDMP Systems:



 


 

 

 

Niels Buch Leander +45 3075 5339nbln@nnit.comManaging Consultanthttps://www.linkedin.com/in/nielsbuchleanderNiels Buch Leander

 
 
 

 

 

SAP IDMP Roundtablehttp://www.nnit.com/Pages/SAPIDMPRoundtable.aspxSAP IDMP Roundtable
IDMP: A dramatic June followed by a prosperous Julyhttp://www.nnit.com/OfferingsAndArticles/Pages/IDMPReflectionsJuly.aspxIDMP: A dramatic June followed by a prosperous July
Reflections on a dramatic month for IDMPhttp://www.nnit.com/OfferingsAndArticles/Pages/ReflectionsonadramaticmonthforIDMP.aspxReflections on a dramatic month for IDMP
Be at the forefront of ISO IDMP - NNIThttp://www.nnit.com/idmpBe at the forefront of ISO IDMP - NNIT
IDMP Acceleratorshttp://www.nnit.com/OfferingsAndArticles/Pages/idmp-accelerators.aspxIDMP Accelerators
IDMP Document Digitalization Servicehttp://www.nnit.com/OfferingsAndArticles/Pages/document-digitalization-service.aspxIDMP Document Digitalization Service
NNIT – your preferred implementation partner for IDMPhttp://www.nnit.com/OfferingsAndArticles/Pages/idmp-implementation-partner.aspxNNIT – your preferred implementation partner for IDMP
Managing CMC Data for IDMP Compliance: What Pharmaceutical Companies Need To Knowhttp://www.nnit.com/OfferingsAndArticles/Pages/managing-cmc-data-for-idmp.aspxManaging CMC Data for IDMP Compliance: What Pharmaceutical Companies Need To Know
Organizational Change Management for ISO IDMP leveraging the mutual industry challengeshttp://www.nnit.com/OfferingsAndArticles/Pages/ocm-idmp.aspxOrganizational Change Management for ISO IDMP leveraging the mutual industry challenges
Is IDMP ≠ MDM?http://www.nnit.com/OfferingsAndArticles/Pages/idmp-mdm.aspxIs IDMP ≠ MDM?