Masterarbeit

The accomplishments of ISO IDMP implementation and the requirement of further adaption in NCAs using the example of BfArM

Robert Crispien (2025)

Summary:

Language: English

ISO IDMP consists of various ISO standards, that cover the entire medicinal product lifecycle. The standards apply to human medicinal products and investigational medicinal products and specify how data elements on substances, medicinal products, organisations and referentials can be structured consistently. These elements are maintained in the SPOR databases of EMA.

The implementation of ISO IDMP in NCAs involves a considerable amount of work. This master thesis deals with the implementation of ISO IDMP and, in particular, the above-mentioned SPOR systems in the database landscape of NCAs, using BfArM as an example. The SPOR systems of the EMA are discussed, as well as their counterparts at BfArM. The contribution of the UNICOM project to the ISO IDMP implementation in the NCAs is also addressed.

In order to gain comprehensive insight into the achievements, but also the hurdles of ISO IDMP implementation at NCA level, expert interviews were conducted with BfArM employees who deal with ISO IDMP in their daily work. The need for further ISO IDMP implementation was also revealed in the expert interviews. An interview guide was created for the expert interviews, which served as a framework for conducting the interviews. Both the interview guide and the complete transcripts of the interviews are included in the annex.

The results of the expert interviews were evaluated using qualitative content analysis and classified into categories that allowed the research question to be answered.

Pages: 37. 

Annexes: 12, Pages: 81.