Breakthrough Solution for Regulatory Data Mining

By 3. July 2016Blog

On March 15th 2016 the ISO IDMP task force meeting resulted in a staged approach on IDMP as well as suggested changes for iteration 1 data attributes and timelines. IDMP is mandatory in Europe since July 1st of 2016. By 2018 iteration 1 data attributes will need to be prepared for submission to the EMA.

Overall IDMP requires the gathering of several hundred attributes per product. For iteration 1 more than 70 data attributes, including clinical particulars, will be required for the IDMP submission. Pharmaceutical companies are recommended to start their preparation early, as a potential non-compliance penalty of up to 5% of gross European revenue may be implied.

The majority of the iteration 1 data will come from unstructured data sources such as SPC’s, xEVPRM messages, eCTD module 3 documents as well as potential other internal data sources such as the RIM system.

Identified data attributes will need to be mapped with controlled vocabulary codes (EV-Codes), indications will need to be mapped with MedDRA codes, substances with GSRS codes and more.

Identified data will need to undergo a quality assurance and data cleaning procedure.

Modern technology can help to automate these process steps of data extraction, data mining, data mapping and data cleaning and saving months of manual work as well as thousands of manual work hours.

Therefore we rate this technology a breakthrough solution. The following 5 minutes video demonstrates the capabilities:

If you are interested in learning more or extracting some of your own data sources, let us now via a brief email to info@cunesoft.com and one of our IDMP experts will demonstrate this to you.

Kind Regards,

Your Cunesoft Team

Rainer Schwarz

Author Rainer Schwarz

Cunesoft CEO - He has over 15 years of experience with compliant software solutions for regulated processes. He worked in senior management positions at CDC Solutions, Liquent and NextDocs. He has a master degree of Social Sciences from the University of Innsbruck and Hong Kong University

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