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NNIT Life Sciences Institute

STAY ON TOP OF REGULATORY CHANGES
Life sciences companies are subject to a myriad of ever-changing external regulations. NNIT excels at assisting life sciences companies to maintain compliance and offers flexible subscription-based services that help your organization monitor and manage external regulatory changes.

​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​Smart updates on the latest regulatory requirements

NNIT has a deep understanding of the requirements and processes required for life sciences companies to obtain and maintain compliance – including the implications for IT systems throughout the organization.

Making your way through the regulatory jungle and keeping track of all the new developments presents a substantial challenge for most organizations.

To get you to the forefront of what is happening within the area of regulation – and to understand how it impacts your business and IT set-up – we have established the NNIT Life Sciences Institute to offer expert guidance and industry perspectives to support companies starting on a digital transformation journey.

The NNIT Life Sciences Institute offers smart subscription-based services that include regular updates, meetings, presentations and guidance on all industry regulations and trends – helping you adapt to changes and requirements well ahead of time.

We continuously monitor all regulatory changes and evaluate their impact across business-critical areas such as strategy, process, application and information.

The two primary focus areas of the NNIT Life Sciences Institute are the upcoming ISO IDMP requirements and the EMA Telematics Strategy. You can explore all our additional ISO IDMP services here and learn more about the IT implications of EMA’s Telematics Strategy here.

ISO IDMP Intelligence

IDMP Update - Online

Within one week after ISO TC215 WG6 meetings or EU SPOR Task Force meeting, an update meeting will be setup to outline key aspects and conclusions, to gauge the impact on your business and project.
Meetings will be conducted online.

IDMP Update - Presentation

At each update meeting a comprehensive set of slides outlining the key messages will be shown. These slides will be exchanged in PowerPoint format, and will enable you to use the content directly in your own projects. Presentations will be available the day after the update session.

IDMP update – Meeting minutes

NNIT meeting minutes from the actual meetings, sharing highlights, decisions and actions.

Complete overview of ISO IDMP Intelligence:

  • Type: Subscription
  • Frequency: 5 updates a year
  • Scope: EU SPOR Task Force + ISO TC215 WG6 meetings
  • Deliverables: 5 webinars + 5 slide decks + 5 meeting minutes 
  • Price: 3,250 EUR yearly

EMA Telematics Intelligence

EU Telematics Strategy - Intelligence Report

Exhaustive report describing the initiatives running under the EU telematics strategy set forth by EMA, evaluating the impact on applications, information and processes resulting in an overall set of recommendations and heat map indicating high priority areas.

To ensure total comprehension of new regulations and provide ample time to plan for implementation, the Life Sciences Institute leverages the NNIT Impact Matrix as part of the EMA Telematics intelligence services. The matrix offers companies a quick overview of regulatory impact factors as well as in-depth information – e.g. what changes should be made at system level to support a given regulatory requirement.

The Impact Matrix includes changes in standard operating procedures and revision cycles, and provides your organization with the ability to proactively accommodate regulatory requirements connected to EMA Telematics – ensuring complete and timely compliance.

Example of NNIT Impact Matrix (at Application Level):    

EU Telematics Strategy - Presentation

Conclusive presentation including an executive brief, detailed slides for each initiative outlined in the intelligence report and sunburst timelines.

 

EU Telematics Strategy - Executive Brief

Intelligence report, high level conclusions and main impact for the management to gain a deeper insight in the exact impact and recommendations put forward by NNIT.

Complete overview of EMA Telematics Intelligence:

  • Type: Subscription
  • Frequency: Bi-annual updates
  • Scope: EU Telematics Strategy
  • Deliverables: Written report (PDF + print) + Presentation (PPT) + Executive Briefing Session
  • Price: 13,250 EUR yearly

 Download extract of Intelligence Report by filling out form:

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Go into depth with Subject Matter Expert Sessions

In addition to the subscription services provided by the Life Sciences Institute, we also offer one-to-one sessions called Subject Matter Expert sessions. These sessions offer direct access to consultancy from industry experts within the Life Sciences Institute team.

The Subject Matter Expert sessions are individually structured and may include in-depth discussions of details in our subscription-based reports or sparring on how individual regulatory changes impact on your business. We also offer sessions on topics outside the scope of the Life Sciences Institute e.g. Big Data, Infrastructure, Track and Trace, and Information Management.

To learn more about how the Life Sciences Institute can help you keep up to date with all regulatory changes, fill out the form below, and we will get in touch as soon as possible.

 Want to learn more about Life Sciences Institute?

 

 

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Rasmus Koch Nelund+45 3079 6411rmne@nnit.com​​Vice Presidenthttps://www.linkedin.com/in/rasmusnelundRasmus Koch Nelund