Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Supporting IDMP implementation through AI-based data extraction - An explorative approach ***

Dr. Niklas Schaumann (Abschlußjahr: 2022)

Summary
Language: English
The introduction of international standards by the ISO has led to many facilitations in various fields of co-operations and interoperability of companies. With regard to medicinal products, there have been several mile stones for the harmonisation of information. The establishment of a uniform way of presentation of the medicinal product’s dossier already shortened the review time of applications as well as ensured the international interoperability and exchangeability of data.
As mentioned before, further processing and extraction of documents need to be carried out to complete the medicinal product’s data set. In the course of this completion, documents from the quality part of the CTD should be transformed into data resources to fulfil the IDMP requirements.
Even if the complete set of data has been accomplished, companies need to setup rules about which departments will be responsible for the maintenance and compliance of these data. The data ownership within the company needs to be clearly defined.
The interoperability of different systems in the enterprise is also a challenge that needs to be tackled in order to achieve full compliance with IDMP and to ensure a proper maintenance of data.
So far, there are several stand-alone software products in use, which reproduce certain data elements as human-readable expressions. Thereby the concept of interoperability is hindered. As a consequence, enterprises should take measures to introduce software solutions which ensure the transfer of resources and information between all of the company’s departments. An appropriate application programming interface might be able to ensure a proper cross-functionality of all software solutions currently present in the enterprise (Figure 1). 

Figure 1: Representation of a possible work-around solution for the establishment of interoperability within a company with different software solutions. An application programming interface connects the RIMS and the enterprise resource planning software so that different departments can access and amend both systems. Own diagram based on graphics by vecteezy.com.

Not only within companies it is crucial to have harmonised data easily accessible through a central portal. With regard to patient safety and drug information, it is of high importance to be able to access data through a central repository. The IDMP data repository gives a unique possibility to transform back some of the structured data of a medicinal product by the use of an API. With this API, patients could be able to select only those certain data elements, which are needed for the safe use of a drug. By the selection of these data elements, the enquired data can be translated back into a human-readable output format in the desired patient’s language.

Pages: 39
Annexes: 1, Pages: 14