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Phase I: What is the impact of ISO IDMP in your company?

​Introduction to ISO IDMP​​​

Most pharmaceutical companies are aware of ISO IDMP, which begins in Europe on 1 July 2016 and with go-live of authorized products and substances in Q2 2019. Comprised of five ISO standards, the legislation is designed to standardize the identification of medicinal products. This will greatly improve pharmacovigilance across entire jurisdictions and reduce counterfeiting, ultimately keeping patients safer.

The impact of ISO IDMP​​

The standards will introduce complex interde-pendencies between the major IT systems in the pharmaceutical company, including your safety, manufacturing, and clinical and regulatory systems. Hence, ISO IDMP will not only impact regulatory affairs, but the entire company. Data will need to be captured in every business unit and compiled into a data warehouse, or some other submission solution, before being sent to the authorities.

What you can do now​

The implementation deadline might seem far away, but the implications across the pharma company are so great that you need to have a business and IT strategy in place in order to avoid problems further down the line.

How NNIT can help you​​

Since no regional implementation guidelines are yet available, concrete changes cannot be made to IT systems yet. However, the ultimate goal is to create a single, authoritative data repository that can be used internally and externally. The first step towards achieving this goal is to make an impact assessment. NNIT’s impact assessment consists of three parts: 

  1. Training and workshops 
    Based on an in-depth understanding of the ISO standards, we first identify stakeholders in your organization and, through training and work-shops, we create the necessary awareness.
  2. Data analysis
    We interview different parts of the organization to understand where the data resides, who owns it and in what format it is stored. By mapping the data sources against the ISO standards, NNIT provides a data overview and a gap analysis, which is the necessary platform for future decision-making. 

  3. Management report
    On the basis of the data analysis, we provide a report that will enable management to create a business strategy, so that the organization knows what to do once the implementation guidelines are available. 

NNIT can also advise on how to create business intelligence opportunities for the company, making its product information far simpler to access and manage. 

 

 

 

 

 

 

NNIT here+45 7024 ​4242nnitcontact@nnit.com ​​​​​​​​​​​​https://dk.linkedin.com/company/nnitNNIT here

 

 

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